ReagentsHaematology / haemostasis / immunohaematology / histology / cytology

Haemostasis reagents (coagulation)

EMDN code W010302

207 manufacturers, 2,000 models including 1,943 on the market, 26 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Dymind EU representative : Eunitor GmbH (Germany)	China	Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT 1 test/kit98/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT 10 tests/kit98/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT 15 tests/kit98/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT 30 tests/kit98/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT R1: 1.0 mL×10, R2 1.0 mL×1098/79 154 others Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT R1: 4.0 mL×1, R2: 4.0 mL×198/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT R1: 4.0 mL×10, R2: 4.0 mL×1098/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT:R2:2.0 mL × 10, R1:2.0 mL × 1098/79 Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) CA-APTT：R1:2.0mL×1,R2:2.0mL×198/79 Activated Partial Thromboplastin Time Assay Kit(Ellagic Acid)(Coagulation Method) CA-APTT Specification 1：R1: 2.0 mL × 10, R2: 2.0 mL × 1098/79 Activated Partial Thromboplastin Time Assay Kit(Ellagic Acid)(Coagulation Method) CA-APTT Specification 2 ：R1: 4.0 mL × 10, R2: 4.0 mL × 1098/79 Activated Partial Thromboplastin Time Assay Kit(Ellagic Acid)(Coagulation Method) CA-APTT Specification 3 ：R1: 1.0 mL × 10, R2: 1.0 mL × 1098/79 Anti-Xa Testing Kit(Chromogenic Assay) CA Anti-Xa Specification 2 ：R1: 4 × 4.0 mL, R2: 4 × 4.0 mL, R3: 4 × 2.0 mL98/79 Anti-Xa Testing Kit(Chromogenic Assay) CA Anti-Xa Specification 3 ：15 tests/kit98/79 Anti-Xa Testing Kit(Chromogenic Assay) CA Anti-Xa Specification 4 ：15×3 tests/kit98/79 Anti-Xa Testing Kit(Chromogenic Assay) CA Anti-Xa Specification 5 ：15×5 tests/kit98/79 Anti-Xa Testing Kit(Chromogenic Assay) CA Anti-Xa Specification 1 ：R1: 4 × 2.0 mL, R2: 4 × 2.0 mL, R3: 4 × 2.0 mL98/79 Antithrombin III Control CTRL-AT III,10 × 1.0 mL (high value)98/79 Antithrombin III Control CTRL-AT III,10 × 1.0 mL (low value)98/79 Antithrombin III Control CTRL-AT III,10×1.0 mL (low value), 10×1.0 mL (high value)98/79 Antithrombin III Control CTRL-AT III,1×1.0 mL (low value), 1×1.0 mL (high value)98/79 Antithrombin III Control CTRL-AT III：1×1.0mL (high value)98/79 Antithrombin III Control CTRL-AT III：1×1.0mL (low value)98/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L) Specification 1：R1: 3.5 mL × 1, R2: 1.0 mL × 1, R3: 5.0 mL × 198/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L) Specification 4：R1: 3.5 mL × 1, R2: 1.0 mL × 198/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L)，1 test/kit98/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L)，10 tests/kit98/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L)，30 tests/kit98/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) CA AT-III (L)，R1: 7.0 mL × 4, R2: 2.0 mL × 498/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) Model : CA AT-III (L) Specification 2: R1: 3.5 mL × 4, R2: 1.0 mL × 4, R3: 5.0 mL × 498/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) Model : CA AT-III (L) Specification 3: R1: 7.0 mL × 4, R2: 2.0 mL × 4, R3: 8.0 mL × 598/79 Antithrombin III Testing Kit (Chromogenic Substrate Method) Model : CA AT-III (L) Specification 9: 15 tests/kit98/79 Antithrombin III Testing Kit (Chromogenic Substratrate Method) CA AT-III (L)，R1: 3.5 mL × 4, R2: 1.0 mL × 498/79 Antithrombin Ⅲ Calibrator Model：CAL AT-III 1× 1.0 mL/kit98/79 Antithrombin Ⅲ Calibrator Model：CAL AT-III 6× 1.0 mL/kit98/79 CTRL Coag Coagulation control (level 1) : 1 × 1.0 mL98/79 CTRL Coag Coagulation control (level 1) : 10 × 1.0 mL98/79 CTRL Coag Coagulation control (level 2) : 1 × 1.0 mL98/79 CTRL Coag Coagulation control (level 2) : 10 × 1.0 mL98/79 D-Dimer Assay Kit (Immunoturbidimetry) CA D-Dimer：R2: 2.0 mL×4, R1: 4.0 mL×498/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification10:15 tests/kit98/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification11:30 tests/kit98/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification3:R2:2.0mL×1,R1:4.0mL×198/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification4:R2:1.0 mL×4,R1:4.0 mL×298/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification5:1.0 mL×498/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification6: 2.0 mL×498/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification7:4.0 mL×498/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification8:1 test/kit98/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification9:10 tests/kit98/79 D-Dimer Assay Kit (Immunoturbidimetry) Model : CA D-Dimer Specification2:R2:4.0 mL×4,R1:4.0 mL×898/79 D-Dimer Calibrator Model : CAL-DD 1×0.5 mL/kit (volume after reconstitution)98/79 D-Dimer Calibrator Model : CAL-DD 6×0.5 mL/kit (volume after reconstitution)98/79 D-Dimer Calibrator Model : CAL-DD 6×1.0 mL/kit (volume after reconstitution)98/79 D-Dimer Control CAL-DD：1 × 1.0 mL/kit98/79 D-Dimer Control CTRL-DD:10×1.0 mL (low value)98/79 D-Dimer Control CTRL-DD：10 × 1.0 mL (high value)98/79 D-Dimer Control Model : CTRL-DD Specification 1:1 × 0.5 mL (low value)98/79 D-Dimer Control Model : CTRL-DD Specification 2:1 × 0.5 mL (high value)98/79 D-Dimer Control Model : CTRL-DD Specification 3:10 × 0.5 mL (low value)98/79 D-Dimer Control Model : CTRL-DD Specification 4:10 × 0.5 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，1 test/kit98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，10 tests/kit98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，30 test/kit98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，R1: 1 × 2.0 mL, R2: 1 × 2.0 mL98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，R1: 2.0 mL × 1, R2: 2.0 mL × 1, R3: 2.0 mL × 198/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，R1: 2.0 mL × 4, R2: 2.0 mL × 498/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，R1: 4 × 2.0 mL, R2: 4 × 2.0 mL, R3: 2 × 2.0 mL98/79 Fibrin and Fibrinogen Degradation Products Assay Kit(Immunoturbidimetry) CA-FDP，R1: 4.0 mL × 4, R2: 4.0 mL × 498/79 Fibrin and Fibrinogen Degradation Products Assay Kit（Immunoturbidimetry） Model : CA-FDP Specification 3:R1: 4 × 4.0 mL, R2: 4 × 4.0 mL, R3: 4 × 2.0 mL98/79 Fibrin and Fibrinogen Degradation Products Assay Kit（Immunoturbidimetry） Model : CA-FDP Specification 9:15 tests/kit98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP,Calibrator 1: 1 × 1.0 mL，Calibrator 2: 1 ×1.0 mL，Calibrator 3: 1 × 1.0 mL，Calibrator 4: 1 × 1.0 mL，Calibrator 5: 1 × 1.0 Ml98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP,Calibrator 1: 2 × 1.0 mL，Calibrator 2: 2 × 1.0 mL，Calibrator 2: 2 × 1.0 mL，Calibrator 3: 2 × 1.0 mL，Calibrator 4: 2 × 1.0 mL，Calibrator 5: 2 ×1.0 mL98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP,Calibrator 5: 3 × 1.0 mL98/79 Fibrin and Fibrinogen Degradation Products Calibrator CAL-FDP，Calibrator 5: 1 × 1.0 mL98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,1 × 0.5 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,1 × 0.5 mL (low value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,1 × 1.0 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,1 × 1.0 mL (low value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10 × 0.5 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10 × 0.5 mL (low value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10 × 1.0 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10 × 1.5 mL (high value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10 × 1.5 mL (low value)98/79 Fibrin and Fibrinogen Degradation Products Control CTRL-FDP,10×1.0mL (low value)98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 1 :R1 2.0 mL× 10, R2 5.0 mL×122 refs98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 2 :R1 4.0 mL× 10, R2 30.0 mL× 52 refs98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 1 test/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 10 tests/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 15 tests/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) 30 tests/kit98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 1.0 mL× 1098/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 1.0 mL× 10, R2: 5.0 mL× 698/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 2.0 mL× 1098/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 4.0 mL× 1, R2: 30.0 mL× 198/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) R1: 4.0 mL× 1098/79 Fibrinogen Calibrator CAL-FIB：1 × 1.0 mL/kit98/79 Fibrinogen Calibrator Model : CAL-FIB Specification 2:6×1.0 mL/kit98/79 Heparin Calibrator CAL Anti-Xa Specification 1：Calibrator 1: 1 ×1.0 mL；Calibrator 2: 1 ×1.0 mL；Calibrator 3: 1 ×1.0 mL98/79 Low Molecular Weight Heparin Control CTRL-LMWH Specification 3 ：10 × 1.0 mL (low-level)98/79 Low Molecular Weight Heparin Control CTRL-LMWH Specification 4 ：10 × 1.0 mL (high-level)98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 1：dRVVT screen: 1 x 2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 2 dRVVT screen: 10 x 1.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 3: dRVVT screen: 10 × 2mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 4 dRVVT confirm: 1 x 2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 5 dRWVT confirm: 10 x 1.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-dRVVT Specification 6: dRVVT confirm: 10 × 2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-SCT Specification 1： SCT screen: 4 × 1.0 mLSCT confirm: 4 × 1.0 mL SCT CaCl2: 4 × 2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-SCT Specification 2： SCT screen: 4 × 2.0 mL SCT confirm: 4 × 2.0 mL SCT CaCl2: 4 × 4.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-SCT Specification 3： SCT screen: 4 × 2.0 mL SCT CaCl2: 4 ×2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-SCT Specification 4： SCT confirm: 4 × 2.0 mL; SCT CaCl2: 4 ×2.0 mL98/79 Lupus Anticoagulant Assay Kit (Coagulation Method) CA LA-SCT Specification 5： 15 tests/kit98/79 Lupus Anticoagulant Control CTRL-LA Specification 1：1 × 1.0 mL (Negative)98/79 Lupus Anticoagulant Control CTRL-LA Specification 2：1 × 1.0 mL (Positive)98/79 Lupus Anticoagulant Control CTRL-LA Specification 3：10 × 1.0 mL (Negative)98/79 Lupus Anticoagulants Control CTRL-LA Specification 4: 10 × 1.0 mL (Positive)98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 1：PC activator: 1×2.0 mL, PC substrate: 1×2.0 mL, PC diluent: 1×5.0 mL98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 2：PC activator: 2×2.0 mL, PC substrate: 2×2.0 mL, PC diluent: 2×5.0 mL98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 3：PC activator: 2×4.0 mL, PC substrate: 2×4.0 mL, PC diluent: 4×5.0 mL98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 4：PC activator: 1×2.0 mL, PC substrate: 1×2.0 mL98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 5：PC activator: 2×2.0 mL, PC substrate: 2×2.0 mL98/79 Protein C Activity Testing Kit(Chromogenic Substrate Method) CA-PC specification 6：PC activator: 2×4.0 mL, PC substrate: 2×4.0 mL98/79 Protein C Calibrator CAL-PC Specification 1：1×0.5 mL/kit (reconstituted volume)98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 1 ：PS buffer: 1×2.0 mL. PS latex reagent: 1×2.0 mL. FPS diluent: 1×3.0 mL98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 2 ：PS buffer: 2×2.0 mL. PS latex reagent: 2×2.0 mL. FPS diluent: 2×3.0 mL98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 3 ：PS buffer: 2×4.0 mL. PS latex reagent: 2×4.0 mL. FPS diluent: 4×3.0 mL98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 4 ：PS buffer: 1×2.0 mL. PS latex reagent: 1×2.0 mL98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 5 ：PS buffer: 2×2.0 mL. PS latex reagent: 2×2.0 mL98/79 Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 6 ：PS buffer: 2×4.0 mL. PS latex reagent: 2×4.0 mL98/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 30 tests/kit98/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 1 test/kit98/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 10 tests/kit98/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 15 tests/kit98/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 2.0 mL × 198/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT Specification 1: 4.0 mL × 1098/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT Specification 2: 2.0 mL × 1098/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT Specification 3: 4.0 mL × 198/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 2.0 mL×1098/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT 4.0 mL×198/79 Prothrombin Time Assay Reagent (Coagulation Method) CA-PT：4.0 mL×1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT Specification 1:5.0 mL× 1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT Specification 2:3.0 mL×1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT Specification 3:1.5 mL×1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT 1.5 mL×1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT 3.0 mL×1098/79 Thrombin Time Assay Reagent (Coagulation Method) CA-TT：5.0 mL× 1098/79 Thrombin Time Assay Reagent（Coagulation Method） CA-TT 1 test/kit98/79 Thrombin Time Assay Reagent（Coagulation Method） CA-TT 10 tests/kit98/79 Thrombin Time Assay Reagent（Coagulation Method） CA-TT 15 tests/kit98/79 Thrombin Time Assay Reagent（Coagulation Method） CA-TT 3.0 mL× 198/79 Thrombin Time Assay Reagent（Coagulation Method） CA-TT 30 tests/kit98/79 Unfractionated Heparin Control CTRL-UFH Specification 1 ：1 × 1.0 mL (low-level)98/79 Unfractionated Heparin Control CTRL-UFH Specification 3 ：10 × 1.0 mL (low-level)98/79 Unfractionated Heparin Control CTRL-UFH Specification 4 ：10 × 1.0 mL (high-level)98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 1 ：VWF buffer: 1 × 2.0 mL, VWF latex reagent: 1 × 2.0 mL, VWF diluent: 1 × 3.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 2 ：VWF buffer: 2 × 2.0 mL, VWF latex reagent: 2 × 2.0 mL, VWF diluent: 2 × 3.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 3 ：VWF buffer: 2 × 4.0 mL, VWF latex reagent: 2 × 4.0 mL, VWF diluent: 4 × 3.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 4 ：VWF buffer: 1 × 2.0 mL, VWF latex reagent: 1 × 2.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 5 ：VWF buffer: 2 × 2.0 mL, VWF latex reagent: 2 × 2.0 mL98/79 Von Willebrand Factor Antigen Testing Kit (Immunoturbidimetry) CA-VWF (Ag) Specification 6 ：VWF buffer: 2 × 4.0 mL, VWF latex reagent: 2 × 4.0 mL98/79	– 98/79	regulationdept@dymind.com EUDAMED record Report an error
Technoclone	Austria	Abnormal Human Control Plasma3 refs AK-Calibrant98/79 AK-Verification2 refs APC Control Kit98/79 APC Resistance Kit2 refs98/79 135 others APIX CalSet APIX ControlSet98/79 CaCl2 25 mM3 refs CaCl2 50 mM2 refs Ceveron TGA CAL98/79 Citrate Buffer2 refs Coagulation CON N3 refs Coagulation Control A98/79 Coagulation Control AK98/79 Coagulation Control N98/79 Coagulation Reference2 refs DABI CalSet DABI ControlSet Dapttin3 refs DTI Chrom EDOX CalSet EDOX ControlSet98/79 Factor II immunads. Deficient Plasma98/79 Factor IX DP2 refs Factor IX immunads. Deficient Plasma98/79 Factor IX native Deficient Plasma98/79 Factor V immunads. Deficient Plasma98/79 Factor VII immunads. Deficient Plasma98/79 Factor VIII DP native2 refs Factor VIII immunads. Deficient Plasma2 refs98/79 Factor VIII INH CON Factor VIII INH Kit2 refs Factor VIII Inhibitor Plasma98/79 Factor X immunads. Deficient Plasma98/79 Factor X native Deficient Plasma98/79 Factor XI immunoads. Deficient Plasma98/79 Factor XI native Deficient Plasma98/79 Factor XII immunoads. Deficient Plasma98/79 Factor XII native Deficient Plasma98/79 Fibrinogen C Fibrinogen Reagent98/79 Fibrinogen Reagent Kit98/79 Fitzgerald Trait Plasma98/79 Fletcher Trait Plasma98/79 Imidazole Buffer3 refs Lupus Anticoagulant Test98/79 Lupus Inhibitor Plasma2 refs98/79 Lupus Inhibitor Plasma Low98/79 NaCl 0.9 % Platelet Poor Plasma98/79 Protein C immunads. Deficient Plasma98/79 Protein S Deficient Plasma98/79 RIVA CalSet RIVA ControlSet Siron LIS3 refs Siron LS3 refs TECHNOCHROM anti-Xa98/79 Technochrom AT manual TECHNOCHROM ATIII98/79 Technochrom Dilution Buffer Technochrom DTI Technochrom FVIII:C 2G Technochrom FVIII:C 2G CAL TECHNOCHROM FXIII98/79 Technochrom Plasmin INH98/79 Technochrom Plasminogen98/79 TECHNOCHROM Protein C98/79 Technochrom Protein C 2G98/79 TECHNOCLOT Control A98/79 Technoclot Control A298/79 TECHNOCLOT Control N98/79 Technoclot dRVVT Confirm98/79 Technoclot dRVVT Screen98/79 Technoclot DTI TECHNOCLOT LA Confirm98/79 TECHNOCLOT LA Screen98/79 TECHNOCLOT Protein C98/79 Technoclot PT Owren capillary CAL set Technoclot PT plus2 refs TECHNOCLOT® PT Owren Capillary Control Set98/79 Technofluor ADAMTS13:Act 0 CAL Technofluor FXIII:Act TECHNOLEIA D-Dimer Calibrator 0 ng/mL98/79 TECHNOLEIA D-Dimer Calibrator ~3000 ng/mL98/79 TECHNOLEIA D-Dimer Control high98/79 TECHNOLEIA D-Dimer Control low98/79 TECHNOLEIA D-Dimer Latex Kit2 refs98/79 Technoplastin HIS4 refs Technoplastin HIS Ceveron3 refs Technoview allXa CON98/79 Technoview Apixaban CAL98/79 Technoview Apixaban CON H98/79 Technoview Apixaban CON L98/79 Technoview Argatroban CAL98/79 Technoview Argatroban CON H2 refs Technoview Arixtra CAL Technoview Arixtra CON H98/79 Technoview Arixtra CON L98/79 Technoview Dabigatran CAL98/79 Technoview Dabigatran CON H2 refs Technoview Edoxaban CAL98/79 Technoview Edoxaban CON H3 refs Technoview LMWH CAL Technoview LMWH CON H2 refs Technoview LMWH CON M98/79 Technoview Orgaran CAL Technoview Orgaran CON H2 refs Technoview Rivaroxaban CAL98/79 Technoview Rivaroxaban CAL H98/79 Technoview Rivaroxaban CON H2 refs Technoview Rivaroxaban CON M98/79 Technoview UFH CAL Technoview UFH CON H98/79 Technoview UFH CON L TECHNOZYM ADAMTS13 Activity CAL Set98/79 TECHNOZYM ADAMTS13 Activity CONT Set98/79 TECHNOZYM ADAMTS13 Antigen CAL Set98/79 TECHNOZYM ADAMTS13 Antigen CONT Set98/79 TECHNOZYM ADAMTS13 CAL Set98/79 TECHNOZYM ADAMTS13 CONT Set98/79 TECHNOZYM ADAMTS13 INH CAL Set98/79 TECHNOZYM ADAMTS13 INH CONT Set98/79 TECHNOZYM PAI-1 Actibind CAL Set98/79 TECHNOZYM PAI-1 Actibind CONT Set98/79 TECHNOZYM PAI-1 Actibind ELISA98/79 TECHNOZYM PAI-1 Antigen CAL Set98/79 TECHNOZYM PAI-1 Antigen CONT Set98/79 TECHNOZYM PAI-1 Antigen ELISA98/79 TECHNOZYM Protein C ELISA98/79 TECHNOZYM t-PA Ag EDTA CONT Set98/79 TECHNOZYM t-PA Ag EDTA ELISA98/79 TECHNOZYM t-PA EDTA CAL Set98/79 TECHNOZYM vWF:Ag CAL Set98/79 TECHNOZYM vWF:Ag CONT Set98/79 TECHNOZYM vWF:Ag ELISA98/79 Technozym VWF:CBA (I)98/79 TECHNOZYM vWF:CBA CAL Set98/79 TECHNOZYM vWF:CBA CONT Set98/79 TECHNOZYM vWF:CBA ELISA98/79 Thrombin Time	A, C IVDR, 98/79	Website regulatory@technoclone.com EUDAMED record Report an error
Stago	France	ADP98/79 Arachidonic acid98/79 Asserachrom® HPIA98/79 Asserachrom® HPIA - IgG98/79 Asserachrom® D-Di98/79 134 others Asserachrom® Free Protein S98/79 Asserachrom® IX:Ag98/79 Asserachrom® PAI-198/79 Asserachrom® PF498/79 Asserachrom® Protein C98/79 Asserachrom® Total Protein S98/79 Asserachrom® tPA98/79 Asserachrom® VWF:CB98/79 Asserachrom® VWF:FVIIIB98/79 Asserachrom® Washing Solution Asserachrom® ß-TG98/79 C.K. Prest® 298/79 C.K. Prest® 598/79 Coag Control N + P98/79 Collagen98/79 D-Di Test®98/79 Epinephrine98/79 Etaloquick®98/79 F.S. Test98/79 F.S. Test Unit98/79 FDP Plasma98/79 PTT Automate 598/79 PTT-LA98/79 SPA 2098/79 SPA Buffer Stachrom® Heparin98/79 Stachrom® PAI98/79 Staclot® LA98/79 STA® - Apixaban Calibrator STA® - Apixaban Control STA® - C.K. Prest® STA® - CaCl2 0.01 M STA® - CaCl2 0.025 M STA® - Coag Control (N + ABN) PLUS STA® - Coag Control N + P STA® - Control LA 1 + 298/79 STA® - Dabigatran Calibrator STA® - Dabigatran Control STA® - Deficient II98/79 STA® - Deficient IX STA® - Deficient V STA® - Deficient VII98/79 STA® - Deficient VIII STA® - Deficient X STA® - Deficient XI98/79 STA® - ECA II STA® - Edoxaban Calibrator STA® - Edoxaban Control STA® - FDP Calibrator98/79 STA® - FDP Control STA® - Fibrinogen 5 STA® - FM Calibrator STA® - FM Control98/79 STA® - Hepanorm® HBPM/LMWH98/79 STA® - Hepato-Prest 102 refs STA® - ImmunoDef II98/79 STA® - ImmunoDef IX98/79 STA® - ImmunoDef VIII STA® - ImmunoDef XI98/79 STA® - ImmunoDef XII98/79 STA® - Liatest® D-Di PLUS STA® - Liatest® FDP STA® - Liatest® FM STA® - Liatest® Free Protein S 22 refs STA® - Liatest® VWF:Ag98/79 STA® - Liquid Anti-Xa 42 refs STA® - Liquid Fib STA® - Multi Hep Calibrator STA® - NeoPTimal 103 refs STA® - Néoplastine® CI Plus 102 refs STA® - Owren-Koller STA® - PTT A 598/79 STA® - Quali-Clot I STA® - Quali-Clot II STA® - Quality HBPM/LMWH STA® - Quality HNF/UFH STA® - Reptilase®98/79 STA® - Routine QC 2 ml STA® - SPA + STA® - Stachrom® AT III 398/79 STA® - Stachrom® AT III 698/79 STA® - Stachrom® Plasminogen98/79 STA® - Stachrom® Protein C STA® - Staclot® APC-R98/79 STA® - Staclot® dRVV Confirm STA® - Staclot® dRVV Screen 22 refs STA® - Staclot® Protein C 1 STA® - Staclot® Protein S98/79 STA® - System Control N+P98/79 STA® - Thrombin 102 refs STA® - Unicalibrator STA® - VWF:Ag Calibrator98/79 STA® - VWF:RCo98/79 STG® - Cal&Fluo98/79 sthemO AT L sthemO CaCl2 M sthemO CK Prest sthemO Complete QC 1&2 sthemO Daily QC 1&2 sthemO DDi M sthemO dRVV confirm sthemO dRVV screen L2 refs sthemO FDP sthemO FDP cal sthemO FDP QC 1&2 sthemO Fib M sthemO FVII QC sthemO Heparin cal sthemO II sthemO IX sthemO LA QC 1&2 sthemO LMWH QC 1&2 sthemO Owren Koller M sthemO PC chrom sthemO PC clot M sthemO PS clot sthemO PS Free L sthemO PS VWF QC 1&2 sthemO PT M sthemO PTT A sthemO Thrombin M sthemO UFH QC 1&2 sthemO Unical sthemO V sthemO VII sthemO VIII sthemO VWF Ag sthemO VWF cal sthemO X sthemO XI System Control N+P98/79 TRAP-698/79 Unicalibrator98/79 Citrate Buffer (no longer marketed)	A, B, C IVDR, 98/79	EUDAMED record Report an error
Medcaptain EU representative : R Sight B.V. (Netherlands)	China	Activated Partial Thromboplastin Time Assay MCC00301E98/79 Activated Partial Thromboplastin Time Assay MCC00302E98/79 Activated Partial Thromboplastin Time Assay MCC00313E98/79 Activated Partial Thromboplastin Time Assay MCC00314E98/79 Activated Partial Thromboplastin Time Assay MCC00316E98/79 99 others Activated Partial Thromboplastin Time Assay W010302010298/79 Anti-Xa Assay MCH00101E98/79 Anti-Xa Assay MCH00102E98/79 Anti-Xa Assay MCH00103E98/79 Anti-Xa Assay MCH00104E98/79 Anti-Xa Assay MCH00133E98/79 Anti-Xa Assay MCH00134E98/79 Anti-Xa Assay MCH00135E98/79 Anti-Xa Assay MCH00136E98/79 Anti-Xa Assay MCH00137E98/79 Anti-Xa Assay MCH00138E98/79 Anti-Xa Assay MCH00139E98/79 Anti-Xa Assay MCH00140E98/79 Anti-Xa Assay MCH00141E98/79 Anti-Xa Assay MCH00142E98/79 Anti-Xa Assay MCH00143E98/79 Anti-Xa Assay MCH00144E98/79 Antithrombin Ⅲ Assay MCC00801E98/79 Antithrombin Ⅲ Assay MCC00802E98/79 Antithrombin Ⅲ Assay MCC00813E98/79 Antithrombin Ⅲ Assay MCC00814E98/79 Antithrombin Ⅲ Assay MCC00815E98/79 Antithrombin Ⅲ Assay MCC00816E98/79 Coagulation Calibrators MCH01701E98/79 Coagulation Calibrators MCH01706E98/79 Coagulation Calibrators MCH01707E98/79 Coagulation Calibrators MCH01708E98/79 Coagulation Calibrators MCH01709E98/79 Coagulation Control MCC00101E98/79 Coagulation Control MCC00102E98/79 Coagulation Control MCC00105E98/79 Coagulation Control MCC00106E98/79 D-Dimer (CLIA)2 refs98/79 D-Dimer Assay MCC00601E98/79 D-Dimer Assay MCC00602E98/79 D-Dimer Assay MCC00621E98/79 D-Dimer Assay MCC00622E98/79 D-Dimer Assay MCC00623E98/79 D-Dimer Assay MCC00624E98/79 D-Dimer Assay MCC00625E98/79 D-Dimer Assay MCC00626E98/79 D-Dimer Assay MCC00627E98/79 D-Dimer Assay MCC00628E98/79 Diluent for Coagulation Analysis3 refs FDP（CLIA）2 refs98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00701E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00702E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00721E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00722E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00723E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00726E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00727E98/79 Fibrin and Fibrinogen Degradation Products Assay MCC00728E98/79 Fibrin and Fibrinogen Degradation Products MCC00724E98/79 Fibrinogen Assay MCC00501E98/79 Fibrinogen Assay MCC00502E98/79 Fibrinogen Assay MCC00513E98/79 Fibrinogen Assay MCC00514E98/79 Fibrinogen Assay MCC00515E98/79 Fibrinogen Assay MCC00516E98/79 Functional Fibrinogen Assay MCT00601E98/79 Functional Fibrinogen Assay MCT00602E98/79 Functional Fibrinogen Assay MCT00603E98/79 Functional Fibrinogen Assay MCT01501E3 refs Lupus Anticoagulant Assay MCH00801E98/79 Lupus Anticoagulant Assay MCH00802E98/79 Lupus Anticoagulant Assay MCH00813E98/79 Lupus Anticoagulant Assay MCH00815E98/79 Lupus Anticoagulant Assay MCH00816E98/79 Lupus Anticoagulant Controls MCH01801E98/79 Lupus Anticoagulant Controls MCH01802E98/79 Lupus Anticoagulant Controls MCH01805E98/79 Lupus Anticoagulant Controls MCH01806E98/79 Plasmin-α2 Plasmin Inhibitor Complex（CLIA）2 refs98/79 Protein C Assay MCH00601E98/79 Protein C Assay MCH00602E98/79 Protein C Assay MCH00609E98/79 Protein C Assay MCH00610E98/79 Protein S Assay MCH00701E98/79 Protein S Assay MCH00702E98/79 Protein S Assay MCH00707E98/79 Prothrombin Time MCC00201E2 refs Prothrombin Time MCC00203E3 refs Special Coagulation Controls MCH01601E98/79 Special Coagulation Controls MCH01602E98/79 Special Coagulation Controls MCH01607E98/79 Special Coagulation Controls MCH01608E98/79 Special Coagulation Controls MCH01609E98/79 Special Coagulation Controls MCH01610E98/79 Thrombin Time MCC00401E98/79 Thrombin Time MCC00402E98/79 Thrombin Time MCC00413E98/79 Thrombin Time MCC00414E98/79 Thrombin Time MCC00415E98/79 Thrombin Time MCC00416E98/79 Thrombin-Anti-thrombin III Complex (CLIA)2 refs98/79 Thromboelastographic Platelet Assay(AA/ADP)8 refs W010302050298/79 Washing Solution MCC01001E3 refs	A, C IVDR, 98/79	Website info@medcaptain.com EUDAMED record Report an error
Instrumentation Laboratory EU representative : Instrumentation Laboratory SpA (Italy)	United States	HemosIL AcuStar ADAMTS13 Activity 0009802048 HemosIL AcuStar D-Dimer 0009802000 HemosIL AcuStar D-Dimer Controls 0009802100 HemosIL AcuStar HIT Controls 0009802122 HemosIL AcuStar HIT-IgG(PF4-H) 0009802028 78 others HemosIL AcuStar VWF Controls 0009802119 HemosIL AcuStar VWF:Ag 0009802020 HemosIL AcuStar VWF:RCo 0009802024 HemosIL Apixaban Calibrators 0020014200 HemosIL Apixaban Controls 0020014300 HemosIL APTT-SP 0020006300 HemosIL Calibration Plasma 0020003700 HemosIL Chromogenic Factor IX 0020001900 HemosIL CL HIT-IgG(PF4-H) 0029706200 HemosIL CL Multi-Ab Controls 0029704000 HemosIL D-Dimer 0020008500 HemosIL D-Dimer 500 0020301000 HemosIL D-Dimer Controls 0020013000 HemosIL D-Dimer HS 0020007700 HemosIL D-Dimer HS 500 0020500100 HemosIL D-Dimer HS 500 Controls 0020013100 HemosIL Dabigatran Calibrators 0020013400 HemosIL Dabigatran Controls 0020013500 HemosIL Direct Thrombin Inhibitor Assay 0020302800 HemosIL dRVVT Confirm 0020301600 HemosIL dRVVT Screen 0020301500 HemosIL Factor II deficient plasma 0020012200 HemosIL Factor IX deficient plasma 0020011900 HemosIL Factor V deficient plasma 0020011500 HemosIL Factor V Leiden (APC Resistance V) 0020008700 HemosIL Factor VII deficient plasma 0020011700 HemosIL Factor VIII deficient plasma 0020011800 HemosIL Factor VIII deficient plasma 0020012800 HemosIL Factor X deficient plasma 0020010000 HemosIL Factor XI deficient plasma 0020011300 HemosIL Factor XII deficient plasma 0020011200 HemosIL Factor XIII Antigen 0020201300 HemosIL Fibrinogen-C 0020301100 HemosIL Fibrinogen-C XL 0020003900 HemosIL Free Protein S 0020002700 HemosIL Heparin 0020009400 HemosIL Heparin Calibrators 0020300600 HemosIL High Abnormal Control Assayed 0020003310 HemosIL Homocysteine 0020007800 HemosIL Homocysteine Controls 0020007900 HemosIL INR Validate 0020010500 HemosIL ISI Calibrate 0020010600 HemosIL LA Negative Control 0020012600 HemosIL LA Positive Control 0020012500 HemosIL Liquid Anti-Xa 00020302601 HemosIL Liquid Antithrombin 0020002500 HemosIL Liquid Antithrombin 0020030100 HemosIL Liquid Antithrombin 0020300400 HemosIL Liquid Antithrombin 0020300440 HemosIL LMW Heparin Controls 0020300200 HemosIL Low Abnormal Control Assayed 0020003210 HemosIL Low Fibrinogen Control 0020004200 HemosIL Normal Control Assayed 0020003110 HemosIL Plasma Coagulation Control Level I 0020010700 HemosIL Plasma Coagulation Control Level II 0020010800 HemosIL Plasmin Inhibitor 0020009200 HemosIL Plasminogen 0020009000 HemosIL ProClot 0008468310 HemosIL ProClot diluent 0008468600 HemosIL Protein C 0020300500 HemosIL Protein S Activity 0020302000 HemosIL PT-Fibrinogen HS PLUS 0008469810 HemosIL Q.F.A. Thrombin (Bovine) 0020301700 HemosIL Q.F.A. Thrombin (Bovine) 0020301800 HemosIL ReadiPlasTin 0020301400 HemosIL RecombiPlasTin 2G (20 mL) 0020003050 HemosIL RecombiPlasTin 2G (8 mL) 0020002950 HemosIL Rivaroxaban Calibrators 0020013600 HemosIL Rivaroxaban Controls 0020013700 HemosIL Silica Clotting Time 0020004800 HemosIL Special Test Control Level 1 0020011000 HemosIL Special Test Control Level 2 0020012000 HemosIL SynthAFax 0020007400 HemosIL SynthASil 0020006800 HemosIL Thrombin Time 0009758515 HemosIL UF Heparin Controls 0020300300 HemosIL von Willebrand Factor Activity 0020004700 HemosIL von Willebrand Factor Antigen 0020002300	A, B, C IVDR	Website Regulatory@werfen.com EUDAMED record Report an error
Biobase EU representative : Luxus Lebenswelt GmbH (Germany)	China	Activated Partial Thromboplastin Time (APTT) Test kit (Coagulation) Reagent:2mL×10,CaCl2:25mL×1（501004）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(abnormal):0.5mL×1（521014）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(abnormal):1.0mL×1（521016）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(normal):0.5mL×1（521013）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(normal):1.0mL×1（521015）98/79 69 others Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Reagent:2.5mL×10,CaCl2:30mL×1（502004）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Reagent:4mL×10,CaCl2:45mL×1（503004）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) Calibrator：1mL×1(91134)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) Quality Control：1mL×2(92146)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×1 R2:6mL×1(702)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(709)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（707）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（710）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（796）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:40mL×3 R2:20mL×2（704）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:32mL×1（792）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:32mL×1（793）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2(705)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2(713)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（715）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（716）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（791）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（798）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×1 R2:20mL×1（703）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2(701)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（706）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（794）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×6 R2:60mL×2（795）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:90mL×1 R2:30mL×1(708)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) Calibrator：1mL×1(91036)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) Quality Control：1mL×1(92031)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×1 R2:6mL×1(702)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(707)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(709)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（710）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（796）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:40ml×3 R2:20ml×2（704）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（705）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（713）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（715）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（716）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（791）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（793）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（798）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:32ml×1（792）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60ml ×1 R2:20ml×1（703）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2(701)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（706）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（794）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60ml×6 R2:60ml×2（795）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:90ml×1 R2:30ml×1（708）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Calibration plasma: 0.5mL×1（511001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Calibration plasma: 1.0mL×1（511002）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried： Reagent:2.5mL×5, Diluent:50mL×2（502001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried：Reagent:1mL×10,Diluent:50mL×2（503001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried：Reagent:2mL×5, Diluent:50mL×2（501001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521002）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521004）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521003）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Freeze-dried：Reagent:2.5mL×10,Reconstitution solution:30mL×1（502003）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Freeze-dried：Reagent:2mL×10,Reconstitution solution:25mL×1（502003）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Freeze-dried：Reagent:4mL×10,Reconstitution solution:45mL×1（503003）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521010）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521012）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521009）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521011）98/79 Thrombin Time (TT) Test Kit (Coagulation) Freeze-dried：Reagent 2.5mL×10, Reconstitution solution 30mL×1（502002）98/79 Thrombin Time (TT) Test Kit (Coagulation) Freeze-dried：Reagent 2mL×10, Reconstitution solution 25mL×1（501002）98/79 Thrombin Time (TT) Test Kit (Coagulation) Freeze-dried：Reagent 4mL×10, Reconstitution solution 45mL×1（503002）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521006）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521008）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521005）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521007）98/79	– 98/79	EUDAMED record Report an error
Siemens Healthcare Diagnostics Products EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	Germany, United Kingdom (ex Northern Ireland)	Antiserum to Human Antithrombin III IVDR_27_MAR EB_C_REAG _AS_ATIII Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_AS_FIB Antiserum to Human Plasminogen IVDR_27_MAR EB_B_REAG_AS_Plasm Batroxobin Reagent IVDR_27_MAR EB_C_REAG_Batrox2 refs BC Thrombin Reagent IVDR_27_MAR EB_C_KIT_BC_Thromb 68 others BC von Willebrand Reagent IVDR_27_MAR EB_C_REAG_BC_vW2 refs Berichrom a2-Antiplasmin IVDR_27_MAR EB_B_KIT_Ber_a2-Antipl3 refs Berichrom Antithrombin III (A) IVDR_27_MAR EB_C_PROF_KIT_Ber_ATIII3 refs Berichrom F XIII IVDR_27_MAR EB_C_KIT_Ber_FXIII2 refs Berichrom Plasminogen IVDR_27_MAR EB_B_KIT_Ber_Plasm3 refs Berichrom Protein C IVDR_27_MAR EB_C_KIT_Ber_Prot_C3 refs Calcium Chloride Solution IVDR_27_MAR EB_A_PROF_REAG_CaCl23 refs Coagulation Factor II Deficient Plasma IVDR_27_MAR EB_B_REAG_FII_Def_Pl3 refs Coagulation Factor IX Deficient Plasma IVDR_27_MAR EB_C_PROF_REAG_FIX_Def_Pl3 refs Coagulation Factor V Deficient Plasma IVDR_27_MAR EB_B_REAG_FV_Def_Pl3 refs Coagulation Factor VII Deficient Plasma IVDR_27_MAR EB_C_REAG_FVII_Def_Pl3 refs Coagulation Factor VIII Deficient Plasma IVDR_27_MAR EB_C_PROF_REAG_FVIII_Def_Pl2 refs Coagulation Factor X Deficient Plasma IVDR_27_MAR EB_C_REAG_FX_Def_Pl3 refs Coagulation Factor XI Deficient Plasma IVDR_27_MAR EB_B_PROF_REAG_FXI_Def_Pl3 refs Coagulation Factor XII Deficient Plasma IVDR_27_MAR EB_B_PROF_REAG_FXII_Def_Pl3 refs Control Plasma N IVDR_27_MAR EB_C_PROF_REAG_CPN3 refs Control Plasma P IVDR_27_MAR EB_C_PROF_REAG_CPP3 refs Dabigatran Standards IVDR_27_MAR EB_C_REAG_Dabi_Stand2 refs Dade Actin Activated Cephaloplastin Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin3 refs Dade Actin FS Activated PTT Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin_FS3 refs Dade Actin FSL Activated PTT Reagent IVDR_27_MAR EB_C_PROF_REAG_Actin_FSL3 refs Dade CA System Buffer IVDR_27_MAR EB_A_PROF_REAG_CA_Sys_Buff3 refs Dade Ci-Trol 1 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 13 refs Dade Ci-Trol 2 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 23 refs Dade Ci-Trol 3 IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 33 refs Dade Ci-Trol Heparin Control, High IVDR_27_MAR EB_C_REAG_Ci-Trol_Hep_Con3 refs Dade Data-Fi Abnormal Fibrinogen Control IVDR_27_MAR EB_C_REAG_Data-Fi_Abn_Fib_Con2 refs Dade Fibrinogen Determination Reagents IVDR_27_MAR EB_C_KIT_Fib_Determ_Reag3 refs Dade Innovin IVDR_27_MAR EB_C_PROF_REAG_Innovin3 refs Dade Owren's Veronal Buffer IVDR_27_MAR EB_A_REAG_OVB3 refs Dade PFA Collagen/ADP Test Cartridge IVDR_27_MAR EB_B_REAG_PFA_Coll_ADP_EPI2 refs Dade Thrombin Reagent IVDR_27_MAR EB_C_REAG_Thromb_Reag3 refs Enzygnost F1+2 monoclonal IVDR_27_MAR EB_C_KIT_Enz_F1+2_mono Enzygnost TAT micro IVDR_27_MAR EB_C_KIT_Enz_TAT_mic Factor VIII Chromogenic Assay IVDR_27_MAR EB_C_KIT_FVIII_Chrom2 refs Fibrinogen Calibrator Kit IVDR_27_MAR EB_C_KIT_Fib_Cal2 refs Imidazole Buffer Solution IVDR_27_MAR EB_A_REAG_Imidazol IMMULITE 2000 D-Dimer IVDR_67_LLB_DUB-C_C_KIT_D-Dimer INNOVANCE Anti-Xa IVDR_27_MAR EB_C_KIT_INN_A-Xa2 refs INNOVANCE Antithrombin IVDR_27_MAR EB_C_PROF_KIT_INN_AT3 refs INNOVANCE Apixaban Standards IVDR_27_MAR EB_C_INN_Riva_Stand3 refs INNOVANCE D-Dimer 2.0 DILUENT IVDR_27_MAR EB_a_PROF_INN_D_Di_Sam_Dil_22 refs INNOVANCE D-Dimer 2.0 IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di_22 refs INNOVANCE D-Dimer IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di3 refs INNOVANCE D-Dimer Sample Diluent IVDR_27_MAR EB_A_PROF_REAG_NN_D-Di_Sam_Dil3 refs INNOVANCE Free PS Ag IVDR_27_MAR EB_B_REAG_INN_Free_PS_Ag2 refs INNOVANCE Heparin Calibrator IVDR_27_MAR EB_C_REAG_INN_Hep_Cal2 refs INNOVANCE Heparin IVDR_27_MAR EB_C_KIT_INN_Hep2 refs INNOVANCE PFA P2Y IVDR_27_MAR EB_B_REAG _INN_PFA_P2Y INNOVANCE VWF Ac IVDR_27_MAR EB_C_KIT_INN_VWF_Ac3 refs IVDR_27_MAR EB_B_KIT _vWF_Ag2 refs IVDR_27_MAR EB_C_KIT_ProC_Ac_R2 refs IVDR_27_MAR EB_C_REAG_Thromboclotin2 refs LA 1 Screening Reagent IVDR_27_MAR EB_B_REAG_LA1/23 refs LA Control High IVDR_27_MAR EB_B_REAG_LA_Con3 refs Multifibren U IVDR_27_MAR EB_C_REAG_Multifib_U3 refs N Antiserum to Human Antithrombin III IVDR_27_MAR EB_C_REAG _N_AS_ATIII N Antiserum to Human Fibrinogen IVDR_27_MAR EB_C_REAG_N_AS_FIB N Antiserum to Human Plasminogen IVDR_27_MAR EB_B_REAG_N_AS_Plasm Pathromtin SL IVDR_27_MAR EB_C_PROF_REAG_Pathr_SL3 refs ProC Control Plasma IVDR_27_MAR EB_C_REAG_ProC_Con2 refs ProC Global IVDR_27_MAR EB_C_KIT_ProC_Glob2 refs Protein C Reagent IVDR_27_MAR EB_C_KIT _ProC_Reag2 refs Protein S Ac IVDR_27_MAR EB_C_KIT_Prot_S_Ac3 refs PT Multi-Calibrator IVDR_27_MAR EB_C_PROF_KIT_PT-Multi_Cal2 refs Standard Human Plasma IVDR_27_MAR EB_C_PROF_REAG_SHP3 refs Test Thrombin Reagent IVDR_27_MAR EB_C_KIT _Test_Thromb3 refs Thromborel S IVDR_27_MAR EB_C_PROF_REAG_Thr_S3 refs	A, B, C IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Dirui EU representative : Emergo Europe B.V. (Netherlands) and 1 other	China	Activated Partial Thromboplastin Time Detection Kit (Coagulation Assay) APTTEllagic Acid Reagent: 10×2mL, Calcium Chloride Solution: 1×51mL98/79 Activated Partial Thromboplastin Time Detection Kit (Coagulation Assay) APTTEllagic Acid Reagent: 10×5mL, Calcium Chloride Solution: 1×51mL98/79 Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay)3 refs Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay) R1: 2×5mL, R2: 1×2mL, R1 Reconstitution Fluid: 1×15mL, OVB Buffer: 1×51mL98/79 Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay) R1: 6×5mL, R2: 3×2mL, R1 Reconstitution Fluid: 1×35mL, OVB Buffer: 1×51mL98/79 50 others Coagulation Analysis Multi-Calibrator3 refs Coagulation Analysis Multi-Calibrator 10×1mL98/79 Coagulation Analysis Multi-Calibrator 1×1mL98/79 Coagulation Analysis Multi-Control3 refs Coagulation Analysis Multi-Control level 1: 10×1mL98/79 Coagulation Analysis Multi-Control level 1: 1×1mL98/79 Coagulation Analysis Multi-Control level 2: 10×1mL98/79 Coagulation Analysis Multi-Control level 2: 1×1mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)3 refs D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL, Calibrator: 6×0.5mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL,Control: Low value 5×1mL, High value 5×1mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL,Diluent: 1×55mL,Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Calibrator: 6×0.5mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL98/79 D-Dimer Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 DIRUI CAL1：1×0.5mL CAL2：1×0.5mL CAL3：1×0.5mL CAL4：1×0.5mL CAL5：1×0.5mL CAL6：1×0.5mL98/79 DIRUI High value:1×0.5mL; Low value:1×0.5mL2 refs98/79 Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay)3 refs Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL98/79 Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL98/79 Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL, Control: Low value 5×1mL, High value 5×1mL, Calibrator: 6×0.5mL98/79 Fibrinogen Detection Kit (Coagulation Assay)3 refs Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×10mL, OVB Buffer: 4×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×2mL, OVB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Fluid Reagent: 10×5mL, OVB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×2.2mL, FIB Reconstitution fluid: 1×30mL, FIB Buffer: 1×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×5mL, FIB Reconstitution fluid: 1×51mL, FIB Buffer: 2×51mL98/79 Fibrinogen Detection Kit (Coagulation Assay) FIB Reagent: 10×5mL, FIB Reconstitution fluid: 1×51mL, FIB Buffer: 2×51mL, Calibrator: 1×1mL98/79 Prothrombin Time Detection Kit (Coagulation Assay)6 refs Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×2 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×2 mL, Control Level 1: 1×1 mL, Control Level 2: 1×1 mL, Calibrator: 1×1 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×5 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Fluid Reagent: 10×5 mL, Control Level 1: 1×1 mL, Control Level 2: 1×1 mL, Calibrator: 1×1 mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Reagent: 10×2.2mL, PT Reconstitution fluid: 1×30mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Reagent: 10×5mL, PT Reconstitution fluid: 1×51mL98/79 Prothrombin Time Detection Kit (Coagulation Assay) PT Reagent: 10×5mL, PT Reconstitution fluid: 1×51mL, Calibrator: 1×1mL98/79 R1: 2×5mL; R2: 1×2mL; OVB Buffer: 1×51 mL; Calibrator: 1×1mL; Control:1×1mL98/79 R1: 5×5mL; R2: 5×5mL; D-Dimer Diluent:1×50mL; Calibrator: 1×1mL; Control Low value:1×1mL; Control High value: 1×1mL98/79 R: 10×2.2mL; FIB Buffer: 1×51mL; FIB Reconstitution Fluid: 1×30mL; Calibrator: 1×1mL98/79 R: 10×2.2mL; PT Reconstitution Fluid: 1×30mL; Calibrator: 1×1mL98/79 R: 10×2.2mL; TT Reconstitution Fluid: 1×3098/79 Sample Diluent Blood Coagulation2 refs Thrombin Time Detection Kit (Coagulation Assay)3 refs Thrombin Time Detection Kit (Coagulation Assay) TT Fluid Reagent: 10×10mL98/79 Thrombin Time Detection Kit (Coagulation Assay) TT Fluid Reagent: 10×2mL98/79 Thrombin Time Detection Kit (Coagulation Assay) TT Fluid Reagent: 10×5mL98/79 Thrombin Time Detection Kit (Coagulation Assay) TT Reagent: 10×5mL, TT Reconstitution fluid: 1×51mL98/79	A, C IVDR, 98/79	EUDAMED record Report an error
HYPHEN BioMed	France	BIOPHEN™ Abnormal Control Plasma3 refs BIOPHEN™ Apixaban Calibrator3 refs BIOPHEN™ Apixaban Control3 refs BIOPHEN™ Arixtra® Calibrator Fondaparinux Calibrator2 refs BIOPHEN™ Arixtra® Control Plasma Fondaparinux Control2 refs 37 others BIOPHEN™ AT anti-(h)-Xa LRT Antithrombin (AT) activity - AntiXa3 refs BIOPHEN™ DiXaI Direct Factor Xa inhibitors (DiXaIs) BIOPHEN™ Edoxaban Calibrator3 refs BIOPHEN™ Edoxaban Control3 refs BIOPHEN™ FIX Factor IX (FIX) chromogenic3 refs BIOPHEN™ FVIII Factor VIII (FVIII) chromogenic2 refs BIOPHEN™ FVIII variant Factor VIII (FVIII) bovine2 refs BIOPHEN™ Heparin Calibrator2 refs BIOPHEN™ Heparin LRT Factor Xa (FXa) inhibitors3 refs BIOPHEN™ LMWH Control C33 refs BIOPHEN™ Normal Control Plasma Control Normal Plasma3 refs BIOPHEN™ Orgaran® Calibrator Danaparoid Calibrator2 refs BIOPHEN™ Orgaran® Control Danaparoid Control2 refs BIOPHEN™ Protein C LRT Protein C chromogenic LRT BIOPHEN™ Protein C Protein C chromogenic BIOPHEN™ Rivaroxaban Calibrator Low3 refs BIOPHEN™ Rivaroxaban Control Low3 refs BIOPHEN™ UFH Calibrator BIOPHEN™ UFH Control C13 refs Calcium Chloride 0.025M3 refs CEPHEN™ aPTT2 refs CEPHEN™ LS aPTT Lupus Sensitive FIBRIPHEN™ LRT3 refs Hemostasis Hepes Buffer2 refs Imidazole buffer3 refs Isotonic Sample Diluent3 refs LIAPHEN™ vWF: Ag Von Willebrand Factor Antigen (vWF: Ag)2 refs Platelet Aggregation -ADP AG001K2 refs Platelet Aggregation -Arachidonic Acid2 refs Platelet Aggregation -Collagen AG005K2 refs Platelet Aggregation -Epinephrine2 refs Platelet Aggregation -Ristocetin AG004K2 refs Special Calcium Chloride Calcium chloride Heparin neutralizing Special Tris-BSA buffer Tris-NaCl-EDTA buffer, pH 7.85 ZYMUTEST™ HIA (Heparin Induced Antibodies) IgG2 refs ZYMUTEST™ HIA (Heparin Induced Antibodies) IgGAM2 refs	A, C IVDR	Website info@hyphen-biomed.com EUDAMED record Report an error
Tcoag	Ireland	Ristocetin TriniCAL Fibrinogen98/79 TriniCAL PC/PS98/79 TriniCAL Reference Plasma98/79 TriniCHECK Abnormal control98/79 37 others TriniCHECK Control 1 (Assayed)98/79 TriniCHECK Control 2 (Assayed)98/79 TriniCHECK D-Dimer 298/79 TriniCHECK D-Dimer 398/79 TriniCHECK Level 198/79 TriniCHECK Level 298/79 TriniCHECK Level 398/79 TriniCHECK LIA Control Set98/79 TriniCHROM Antithrombin IIa98/79 TriniCHROM Factor VIII:C TriniCLOT Calcium Chloride 0.025M98/79 TriniCLOT aPTT HS 10 mL98/79 TriniCLOT aPTT HS 3 mL98/79 TriniCLOT APTT S 10ML98/79 TriniCLOT aPTT S 5 mL2 refs98/79 TriniCLOT Automated aPTT 6 mL98/79 TriniCLOT Factor II98/79 TriniCLOT Factor IX98/79 TriniCLOT Factor VII98/79 TriniCLOT Factor VIII98/79 TriniCLOT Factor X98/79 TriniCLOT Factor XI98/79 TriniCLOT Factor XII98/79 TriniCLOT Fibrinogen 6 mL98/79 TriniCLOT Fibrinogen Kit98/79 TriniCLOT Imidazole Buffer98/79 TriniCLOT Lupus Confirm98/79 TriniCLOT Owrens Buffer TriniCLOT PC II98/79 TriniCLOT PS II98/79 TriniCLOT PT Excel S 20 mL98/79 TriniCLOT PT Excel S 6ml98/79 TriniCLOT Thrombin Time 1ml98/79 TriniCLOT Thrombin Time 4ml98/79 TriniLIA D-dimer98/79 TriniLIA D-Dimer II98/79 W010302060698/79	A, B IVDR, 98/79	Website EUDAMED record Report an error
Sanymed	Italy	aPTT - Tromboplastina parz. attivata / Activated Part. Thromboplastin (Ellagic Acid) Bulk R1:1000mL + R2:1000mL98/79 aPTT - Tromboplastina parz. attivata / Activated Part. Thromboplastin (Ellagic Acid) Coagulation R1:2x4mL + R2:2x4mL98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) BT Line R1:1x40mL - 160 Test98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) Bulk R1:1000mL98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) MULTI-PURPOSE KIT R1:2x20mL98/79 33 others ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) SA1500/2500 R1:1x40mL - 160 Test98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) SA2000 R1:2x20mL - 160 Test98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) SA3500/4500/330 R1:1x40mL - 160 Test98/79 ATIII - Antitrombina III / Antithrombin III (Immunoturbidimetric) Sphera R1:1x40mL - 160 Test98/79 ATIII - Antitrombina III / Antithrombin III (RID) RID R1: 1x15 Test98/79 Coag Cal - Coagulazione CAL / Coagulation CAL Coagulation R1: 6x1ml (Lyophilized)98/79 Coag Ctrl H - Coagulazione CTRL H / Coagulation CTRL H Coagulation R1: 6x1ml (Lyophilized)98/79 Coag Ctrl N - Coagulazione CTRL N / Coagulation CTRL N Coagulation R1: 6x1ml (Lyophilized)98/79 D-D - D-Dimero / D-Dimer (Turbilatex) BT Line R1:1x24mL + R2:1x8mL - 120 Test98/79 D-D - D-Dimero / D-Dimer (Turbilatex) Bulk R1:750mL + R2:250mL98/79 D-D - D-Dimero / D-Dimer (Turbilatex) MULTI-PURPOSE KIT R1:2x12mL + R2:1x8mL98/79 D-D - D-Dimero / D-Dimer (Turbilatex) SA1500/2500 R1:1x24mL + R2:1x8mL - 120 Test98/79 D-D - D-Dimero / D-Dimer (Turbilatex) SA2000 R1:1x24mL + R2:1x8mL - 100 Test98/79 D-D - D-Dimero / D-Dimer (Turbilatex) SA3500/4500/330 R1:1x48mL + R2:1x16mL - 240 Test98/79 D-D - D-Dimero / D-Dimer (Turbilatex) Sphera R1:1x24mL + R2:1x8mL - 120 Test98/79 D-D Cal H - D-Dimero CAL H / D-Dimer CAL H MULTI-PURPOSE KIT CAL: 1x1mL (Lyophilized)98/79 D-D Ctrl - D-Dimero CTRL 2 Liv. / D-Dimer CTRL 2 Lev. MULTI-PURPOSE KIT CTL1: 1x1mL + CTL2: 1x1mL (Lyophilized)98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) BT Line R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) Bulk R1:1000mL98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) MULTI-PURPOSE KIT R1:2x20mL98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA1500/2500 R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA2000 R1:2x20mL - 140 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) SA3500/4500/330 R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (Immunoturbi.) Sphera R1:1x40mL - 160 Test98/79 FIB - Fibrinogeno / Fibrinogen (RID) RID R1: 1x15 Test98/79 FIB Cal - Fibrinogeno CAL / Fibrinogen CAL MULTI-PURPOSE KIT CAL: 3x0,5mL (Lyophilized)98/79 FIB Ctrl - Fibrinogeno CTRL 2Liv. / Fibrinogen CTRL 2 Lev. MULTI-PURPOSE KIT CTL1: 2x1,5mL + CTL2: 2x0,7mL (Lyophilized)98/79 Fib-C - Fibrinogeno Clauss / Fibrinogen Clauss (Clauss) Coagulation R1:3x3mL + CAL: 1x1ml + CTRL:1x1mL + DIL: 1x9mL (Lyophilized)98/79 Im - Imidazolo / Imidazole (for Fibrinogen) Coagulation R1: 2x50ml98/79 KAO - Caolino / Kaolin (for Fibrinogen) Coagulation R1: 8x1ml98/79 PT - Tempo di Protrombina / Prothrombin Time (Rabbit Brain) Bulk R1:1000mL98/79 PT - Tempo di Protrombina / Prothrombin Time (Rabbit Brain) Coagulation R1:10x5mL98/79 PT - Tempo di Protrombina / Prothrombin Time (Rabbit Brain) Coagulation R1:4x5mL98/79	– 98/79	Website info@sanymed.it EUDAMED record Report an error
Nordic Biomarker	Sweden	Control Level 12 refs Control Level 22 refs D-Dimer Calibrator K50452 refs D-Dimer Control High SC109K D-Dimer Control Low SC108K 28 others D-Dimer Latex LRT3 refs D-Dimer PBS Diluent2 refs MRX Antithrombin98/79 MRX Antithrombin Calibrator98/79 MRX APTT2 refs MRX Blue D-dimer MRX Blue Free Protein S98/79 MRX Calcium Chloride3 refs MRX D-dimer DDU Calibrator MRX FDP Clear Calibrator Set98/79 MRX Fib Clauss98/79 MRX Fib Clauss Calibrator98/79 MRX Free Protein S Calibrator98/79 MRX Green D-dimer MRX Green FDP98/79 MRX Green vWF Antigen98/79 MRX Laboratory Water MRX Protein C98/79 MRX Protein C Calibrator98/79 MRX PT Buffer3 refs MRX PT Quick98/79 MRX PT Quick (INR) Calibrator Set98/79 MRX Red Free Protein S98/79 MRX Sample Diluent2 refs MRX Specialty Abnormal Control MRX Specialty Normal Control MRX Thrombin Time98/79 MRX vWF Antigen Calibrator98/79	A, C IVDR, 98/79	Website info@nordicbiomarker.com EUDAMED record Report an error
Sclavo	Italy	APTT-E K3000205098/79 D DIMER GREEN K3000408BK98/79 FATTOE I PLASMA IMMUNODEPLETO K2910579098/79 FATTORE PLASMA IMMUNODEPLETO K2910579798/79 FATTORE IX PLASMA IMMUNODEPLETO K2910579498/79 26 others FATTORE V PLASMA IMMUNODEPLETO K2910579198/79 FATTORE VII PLASMA IMMUNODEPLETO K2910579298/79 FATTORE VIII PLASMA IMMUNODEPLETO K2910579398/79 FATTORE X - PLASMA IMMUNODEPLETO K2910579598/79 FATTORE XI PLASMA IMMUNODEPLETO K2910579698/79 K2900518598/79 K2900530198/79 LAC CONFIRM K3001100698/79 LAC SCREEN K3001000698/79 PROTEINA C CROMOGENICA K2910554398/79 PROTEINA S LIBERA K2900552598/79 Sclavo %PT Direct INR Kit K2900549098/79 Sclavo Abnormal Control Plasma Kit K2900530298/79 Sclavo Antithrombin (Factor Xa) Kit K2900500098/79 Sclavo APTT-S Kit K2900555898/79 Sclavo APTT-S Kit K2900555998/79 Sclavo Auto D-Dimer High Control Kit K2910551098/79 Sclavo Auto D-Dimer Kit K2910550198/79 Sclavo Auto D-Dimer Low Control Kit K2910550998/79 Sclavo Cloruro di Calcio 0.025M K25001902 Sclavo Fibrinogen Kit K2905376298/79 Sclavo Fibrinogen Kit K2905376598/79 SCLAVO PT READY QUICK K2900500598/79 Sclavo PT-HRTF Kit K2900600898/79 Sclavo PT-HRTF Kit K2900601898/79 SCLAVO TT KIT K2900539298/79	A IVDR, 98/79	qa@sclavo.it EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	100 Tests/Kit98/79 10mL×1098/79 200 Tests/Kit98/79 2mL×1098/79 50 Tests/Kit2 refs98/79 25 others 5mL×1098/79 R1: 10 mL×10, R2: 120 mL×198/79 R1: 10mL×10, R2: 120mL×198/79 R1: 1mL×10, R2: 15mL×12 refs98/79 R1: 1mL×5, R2: 100mL×1, R3: 1mL×198/79 R1: 1mL×5, R2: 15mL×12 refs98/79 R1: 1mL×5, R2: 50mL×1, R3: 1mL×198/79 R1: 20ml x1, R2: 20ml x 198/79 R1: 3ml x 6, R2: 3ml x 698/79 R1: 3ml x 9, R2: 3ml x32 refs98/79 R1: 4ml x 9, R2: 4ml x 32 refs98/79 R1: 5ml x 9, R2: 5ml x 32 refs98/79 R1:10mL×10，R2:60mL×22 refs98/79 R1:2ml×10,R2:30ml×12 refs98/79 R1:2ml×5,R2:100ml×1,R3:1ml×12 refs98/79 R1:30mL×1 R2:10mL×12 refs98/79 R1:30mL×2 R2:10mL×22 refs98/79 R1:3mL×6 R2:3mL×22 refs98/79 R1:4mlx5,R2:100ml×1,R3:1ml×198/79 R1:4ml×10,R2:50ml×12 refs98/79 R1:4mL×5,R2:100mL×1,R3:1mL×198/79 R1:5mL×10，R2:60mL×12 refs98/79 R1:8mL×5,R2:100mL×2,R3:1mL×12 refs98/79 R1:9mL×3 R2:3mL×32 refs98/79 R1:9mL×6 R2:3mL×62 refs98/79	– 98/79	Website support@rayto.com EUDAMED record Report an error
Shenzhen Drawray Biotech EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	30 Tests/kit D-Dimer 20 tests/kit98/79 D-Dimer 5 tests/kit98/79 iStar-D-dimer 30 Tests98/79 iStar-D-dimer Ⅱ 25 Tests/kit98/79 21 others iStar-D-dimer Ⅱ 2×25 Tests/kit98/79 iStar-D-dimer Ⅱ 2×50 Tests/kit98/79 iStar-D-dimer Ⅱ 30 Tests/kit98/79 iStar-FDP 25 Tests/kit98/79 iStar-FDP 2×25 Tests/kit98/79 iStar-FDP 2×50 Tests/kit98/79 iStar-FDP 30 Tests/kit98/79 iStar-PIC 25 Tests/kit98/79 iStar-PIC 2×25 Tests/kit98/79 iStar-PIC 2×50 Tests/kit98/79 iStar-PIC 30 Tests/kit98/79 iStar-t-PAIC 25 Tests/kit98/79 iStar-t-PAIC 2×25 Tests/kit98/79 iStar-t-PAIC 2×50 Tests/kit98/79 iStar-t-PAIC 30 Tests/kit98/79 iStar-TAT 25 Tests/kit98/79 iStar-TAT 2×25 Tests/kit98/79 iStar-TAT 2×50 Tests/kit98/79 iStar-TAT 30 Tests/kit98/79 Unicorn-D-dimer 20 Tests/kit98/79 Unicorn-D-dimer 5 Tests/kit98/79	C IVDR, 98/79	Website info@szdrawray.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others	China	40 tests/kit3 refs98/79 ACT CoaguDx Test Strip 12 Strips / Kit98/79 ACT CoaguDx Test Strip 24 Strips / Kit98/79 ACT CoaguDx Test Strip 48 Strips / Kit98/79 ACT CoaguDx Test Strip 6 Strips / Kit98/79 24 others APTT CoaguDx Test Strip 12 Strips / Kit98/79 APTT CoaguDx Test Strip 12 Strips / Kit (Note: One-step method)98/79 APTT CoaguDx Test Strip 24 Strips / Kit98/79 APTT CoaguDx Test Strip 24 Strips / Kit (Note: One-step method)98/79 APTT CoaguDx Test Strip 48 Strips / Kit98/79 APTT CoaguDx Test Strip 48 Strips / Kit (Note: One-step method)98/79 APTT CoaguDx Test Strip 6 Strips / Kit98/79 APTT CoaguDx Test Strip 6 Strips / Kit (Note: One-step method)98/79 APTT CoaguDx Test Strip 96 Strips / Kit (Note: One-step method)98/79 D-Dimer Test Kit (Immunofluorescence Method) 20 tests/kit98/79 PT CoaguDx Test Strip 12 Strips / Kit98/79 PT CoaguDx Test Strip 12 Strips / Kit (Note: One-step method)98/79 PT CoaguDx Test Strip 24 Strips / Kit98/79 PT CoaguDx Test Strip 24 Strips / Kit (Note: One-step method)98/79 PT CoaguDx Test Strip 48 Strips / Kit98/79 PT CoaguDx Test Strip 48 Strips / Kit (Note: One-step method)98/79 PT CoaguDx Test Strip 6 Strips / Kit98/79 PT CoaguDx Test Strip 6 Strips / Kit (Note: One-step method)98/79 PT CoaguDx Test Strip 96 Strips / Kit (Note: One-step method)98/79 20 tests/kit2 refs98/79 (no longer marketed) 5×4 mL98/79 (no longer marketed) Reagent 1: 5×5mL Reagent 2: 5×5mL98/79 (no longer marketed) Reagent 1：5×5 mL Reagent 2：5×5 mL Dilution：2×5 mL98/79 (no longer marketed) Reagent：5×5 mL Buffer：5×10 mL98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Biolabo	France	BE APTT K APTT Kaolin + CaCl23 refs BE APTT SL APTT Silica + CaCl23 refs BE Cal Ref Reference Plasma2 refs BE Cal Set Calibration Plasma PT Prothrombin Time Standard Set2 refs BE DDimer D-DIMER Turbidimetric Immunoassay3 refs 17 others BE DDTrol 1 DDimer Plasma low D-DIMER Controls3 refs BE Factor II Deficient Plasma FII2 refs BE Factor IX Deficient Plasma FIX2 refs BE Factor V Deficient Plasma FV2 refs BE Factor VII Deficient Plasma FVII2 refs BE Factor VIII Deficient Plasma FVIII2 refs BE Factor X Deficient Plasma FX2 refs BE Factor XI Deficient Plasma FXI2 refs BE Factor XII Deficient Plasma FXII2 refs BE FIB Thrombin Kaolin + Buffer Fibrinogen Reagents3 refs BE Owren Buffer2 refs BE PT HI Thromboplastin high ISI Prothrombin Time (High ISI)3 refs BE PT LI Thromboplastin low ISI Prothrombin Time (Low ISI)3 refs BE Trol 1 Plasma Level 1 CONTROL PLASMAS with coagulation factors3 refs BE TT Thrombin Time2 refs CALCIUM CHLORIDE 0.025M CHLORURE DE CALCIUM 0,025M CONTROL PLASMA Level 1 CONTROL PLASMAS without coagulation factors3 refs	A, B, C IVDR	support@biolabo.fr EUDAMED record Report an error
Lifotronic EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other	China	D-dimer Assay Kit (Lateral Flow Immunoassay) 50 Tests/Kit98/79 D-Dimer STAT (eCLIA) 100T98/79 D-Dimer STAT (eCLIA) 2×100T98/79 D-Dimer STAT (eCLIA) 2×50T98/79 D-Dimer STAT (eCLIA) 50T，2×50T，100T，2×100T2 refs 17 others D-dimer Assay Kits (Lateral Flow Immunoassay)3 refs FDP (eCLIA) 100T98/79 FDP (eCLIA) 2×50T98/79 FDP (eCLIA) 50T98/79 FDP (eCLIA) 50T, 2×50T, 100T, 2×100T PIC (eCLIA) 100T98/79 PIC (eCLIA) 2×100T98/79 PIC (eCLIA) 2×50T98/79 PIC (eCLIA) 50T98/79 t-PAIC (eCLIA) 100T98/79 t-PAIC (eCLIA) 2×100T98/79 t-PAIC (eCLIA) 2×50T98/79 t-PAIC (eCLIA) 50T98/79 TAT (eCLIA) 100T98/79 TAT (eCLIA) 2×100T98/79 TAT (eCLIA) 2×50T98/79 TAT (eCLIA) 50T98/79	C IVDR, 98/79	Website EUDAMED record Report an error
Syscanbio EU representative : Obelis s.a. (Belgium)	China	Activated Partial Thromboplastin Time (APTT) Reagent(Ellagic Acid) Coagulation Analyzer2 refs98/79 Antithrombin III Assay Kit Coagulation Analyzer Ci-AT-1298/79 Antithrombin III Assay Kit Coagulation Analyzer Ci-AT-2498/79 Antithrombin III Assay Kit Coagulation Analyzer CP-AT-100098/79 Antithrombin III Control Coagulation Analyzer ATIII-0198/79 16 others Antithrombin III Control Coagulation Analyzer ATIII-0298/79 Coagulation Analyzer Ci-APTT-10E98/79 Coagulation Control Plasma Coagulation Analyzer CONP-I-0198/79 Coagulation Control Plasma Coagulation Analyzer CONP-II-0198/79 D-Dimer Assay Kit Coagulation Analyzer Ci-DD-1298/79 D-Dimer Assay Kit Coagulation Analyzer Ci-DD-2498/79 D-Dimer Assay Kit Coagulation Analyzer CP-DD-100098/79 D-Dimer Control Coagulation Analyzer ATIII-0198/79 D-Dimer Control Coagulation Analyzer DDI-0198/79 D-Dimer Control Coagulation Analyzer DDII-0198/79 Fibrin Degradation Product (FDP) Assay Kit Coagulation Analyzer2 refs98/79 Fibrin Degradation Product (FDP) Control Coagulation Analyzer2 refs98/79 Fibrinogen Reference Plasma Coagulation Analyzer STD-FIB-0198/79 Prothrombin Time (PT) Reagent Coagulation Analyzer2 refs98/79 Thrombin Reagent (for Fbg assay) Coagulation Analyzer3 refs98/79 Thrombin Time (TT) Reagent Coagulation Analyzer3 refs98/79	– 98/79	EUDAMED record Report an error
TECO Medical Instruments, Production + Trading	Germany	Blue D-Dimer LC98/79 Red D-Dimer D2010-01298/79 TECal DD98/79 TECal N98/79 TEChrom98/79 16 others TEClot APTT-S98/79 TEClot Factor II Deficient Plasma98/79 TEClot Factor IX Deficient Plasma98/79 TEClot Factor V Deficient Plasma98/79 TEClot Factor VII Deficient Plasma98/79 TEClot Factor VIII Deficient Plasma98/79 TEClot Factor X Deficient Plasma98/79 TEClot Factor XI Deficient Plasma98/79 TEClot Factor XII Deficient Plasma98/79 TEClot FIB2 refs98/79 TEClot PT-B98/79 TEClot PT-S3 refs98/79 TEClot TT98/79 TEControl A98/79 TEControl A Plus98/79 TEControl N98/79	– 98/79	Website info@teco-medical.com EUDAMED record Report an error
Maccura EU representative : Humiss International B.V. (Netherlands) and 1 other	China	APTT4 refs98/79 Coagulation Analyzer Wash Buffer A (Coa-Wash A) 200.0 mL×2 Coagulation Analyzer Wash Buffer B (Coa-Wash B) 20.0 mL×12 Coagulation Quality Control Plasma (CQC)8 refs98/79 D-Dimer Calibrator EBL218100598/79 14 others D-Dimer Calibrator EBL218200598/79 D-Dimer Calibrator EBL218300598/79 D-Dimer EBL210100898/79 D-Dimer EBL210200898/79 D-Dimer EBL210300898/79 D-Dimer EBL210400898/79 D-Dimer EBL210500898/79 D-Dimer EBL210600898/79 D-Dimer EBL210700898/79 Fibrinogen (Fib)4 refs98/79 Fibrinogen Degradation Product (FDP)7 refs98/79 Fibrinogen Degradation Product (FDP) Calibrator98/79 Prothrombin Time (PT)5 refs98/79 Thrombin Time (TT)4 refs98/79	A IVDR, 98/79	Website EUDAMED record Report an error
Zybio EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Activated Partial Thromboplastin Time Reagent Kit (Clotting Method)3 refs Anti-Xa Controls3 refs Anti-Xa Reagent Kit (Chromogenic Substrate Method)3 refs Antithrombin Ⅲ Reagent Kit (Chromogenic Substrate Method)3 refs Coagulation Controls2 refs 14 others D-Dimer (D-D) Kit(Latex Enhanced Immunoturbidimetric Method)2 refs98/79 D-Dimer Assay (CLIA)98/79 D-Dimer Controls2 refs D-Dimer Reagent Kit (Immunoturbidimetric Method)3 refs Diluent3 refs Fibrin/fibrinogen Degradation Products (FDP) Controls2 refs Fibrin/fibrinogen Degradation Products (FDP) Reagent Kit (Immunoturbidimetric Method)3 refs Fibrinogen (FIB) Kit (Immunoturbidimetric Method)98/79 Fibrinogen Reagent Kit (Clotting Method)3 refs Prothrombin Time Reagent Kit (Clotting Method)3 refs TH-PClean3 refs TH-PDesorb2 refs TH-SP-Diluent2 refs Thrombin Time Reagent Kit (Clotting Method)3 refs	A, C IVDR, 98/79	PMS@zy-ivd.com EUDAMED record Report an error
Aesku	Germany	AESKULISA® Annexin V-GM98/79 AESKULISA® Cholin-GM98/79 AESKULISA® Ethanolamine-A98/79 AESKULISA® Ethanolamine-GM98/79 AESKULISA® Free Protein S98/79 13 others AESKULISA® HiT II98/79 AESKULISA® HiT II Check98/79 AESKULISA® Inositol-GM98/79 AESKULISA® Phospholipid-8Pro-A98/79 AESKULISA® Phospholipid-8Pro-GM98/79 AESKULISA® Phospholipid-Screen98/79 AESKULISA® Phospholipid-Screen-A98/79 AESKULISA® Phospholipid-Screen-GM98/79 AESKULISA® Protein C98/79 AESKULISA® Protein S98/79 AESKULISA® Sphingomyelin-GM98/79 AESKULISA® Thrombin-Check98/79 AESKULISA® Thrombin-GM98/79	– 98/79	Website EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany)	Egypt	APTT Reagent (SP-UNICELIN) 626 00198/79 APTT Reagent (SP-UNICELIN) 626 00298/79 D-Dimer Turbi Latex98/79 D-Dimer Turbi Latex 585 001-198/79 D-Dimer Turbi Latex 585 00298/79 12 others D-Dimer Turbi Latex 585 002-198/79 D-Dimer Turbi Latex 585 00398/79 D-Dimer Turbi Latex 585 00498/79 FIBRINOGEN 590 00198/79 Fibrinogen-LS Clauss Clotting Time Method 631 00198/79 Fibrinogen-LS Clauss Clotting Time Method 631 00298/79 PT Reagent (SP-Normoplastin) 614 00198/79 PT Reagent (SP-Normoplastin) 614 00298/79 Recoplastin ISI 1.0 PT Reagent 624 00098/79 Recoplastin ISI 1.0 PT Reagent 624 00198/79 Recoplastin ISI 1.0 PT Reagent 624 00298/79 Recoplastin ISI 1.0 PT Reagent 624 00398/79	– 98/79	Website info@spectrum-diagnostics.com EUDAMED record Report an error
Erba	Czechia	Erba Actime 3098/79 Erba Actime 5098/79 Erba Calcium Chloride98/79 Erba Control N98/79 Erba Control P98/79 12 others Erba DDimer Control N+P98/79 Erba DDimer R 6098/79 Erba Protime 2098/79 Erba Protime 4098/79 Erba Protime LS 1098/79 Erba Protime LS 10098/79 Erba Protime LS 5098/79 Erba PT - INR Multical98/79 Erba Standard Plasma98/79 Erba Thrombin Reagent 1098/79 Erba Thrombin Reagent 2098/79 Erba Thrombin Time 2098/79	– 98/79	Website EUDAMED record Report an error
Hartbio EU representative : Amstermed UK Ltd (Northern Ireland)	United Kingdom (ex Northern Ireland)	Hart Biologicals HB-5502-FG98/79 Hart Biologicals HB-5504-FG98/79 Hart Biologicals HB-5506-FG98/79 Hart Biologicals HB-5508-FG98/79 Hart Biologicals HB-5509-FG98/79 11 others Hart Biologicals HB-5511-FG98/79 Hart Biologicals HB-5514-FG98/79 Hart Biologicals HB-5515-FG98/79 Hart Biologicals HB-5533-FG98/79 Hart Biologicals HB-5548-FG98/79 Hart Biologicals HB-5613-FG98/79 Hart Biologicals HB-5614-FG98/79 Hart Biologicals HB-5615-FG98/79 Hart Biologicals HB-5616-FG98/79 Hart Biologicals HB-5617-FG98/79 Hart Biologicals HB-5618-FG98/79	– 98/79	EUDAMED record Report an error
Horiba	France	Yumizen G APTT 4 130003637798/79 Yumizen G APTT Liq 2 130003637998/79 Yumizen G APTT Liq 4 130003638198/79 Yumizen G AT 130003639098/79 Yumizen G CaCl2 4 1300036386 11 others Yumizen G CAL 1300036416 Yumizen G CTRL DDi I & II 130003641498/79 Yumizen G CTRL I & II 1300036412 Yumizen G DDi 2 130003639198/79 Yumizen G FIB 2 130003638398/79 Yumizen G FIB 5 130003638498/79 Yumizen G PT 5 130003633898/79 Yumizen G PT Liq 4 130003637398/79 Yumizen G PT Reco 10 130003637698/79 Yumizen G PT Reco 5 130003637598/79 Yumizen G TT 130003638298/79	A, C IVDR, 98/79	EUDAMED record Report an error
r2 Diagnostics EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United States	Emicizumab Calibrator98/79 Emicizumab Controls98/79 FibroTek Fibrinogen kit98/79 LupoTek Correctin VL98/79 LupoTek Detectin VL98/79 11 others LupoTek KCT98/79 NoFact IX98/79 NoFact VIII98/79 Phospholin ES2 refs98/79 Phosphoplastin RL2 refs98/79 PlasmaCon L198/79 PlasmaCon L298/79 PlasmaCon LA98/79 PlasmaCon N98/79 T-Tek98/79 ThromboTek PSe98/79	– 98/79	Website qa@r2diagnostics.com EUDAMED record Report an error
AIDA	Germany	Annexin V-GM98/79 Choline-GM98/79 Ethanolamin-A98/79 Ethanolamin-GM98/79 Free Protein S98/79 10 others HiT II98/79 HiT II Check98/79 Inositol-GM98/79 Phospholipid Screen-GM98/79 Phospholipid-Screen98/79 Protein C98/79 Protein S98/79 Sphingomyelin98/79 Thrombin-Check98/79 Thrombin-GM98/79	– 98/79	EUDAMED record Report an error
Human	Germany	HemoStat Antithrombin liquid98/79 HemoStat aPTT-EL4 refs98/79 HemoStat Calibrator98/79 HemoStat Control Plasma abnormal98/79 HemoStat Control Plasma normal98/79 8 others HemoStat D-Dimer2 refs98/79 HemoStat D-Dimer Control high/low98/79 HemoStat Fibrinogen98/79 HemoStat free Protein S98/79 HemoStat Protein C HemoStat Thrombin Time98/79 HemoStat Thromboplastin liquid98/79 HemoStat Thromboplastin-SI2 refs98/79	B IVDR, 98/79	Website EUDAMED record Report an error
Steellex EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	10010198/79 10×10ml98/79 10×2ml2 refs98/79 10×5ml2 refs98/79 L1 10×1ml98/79 8 others L2 101mL98/79 R1:510ml R2:330ml98/79 R1:510ml R2:510ml98/79 R1:52ml R2:330ml98/79 R1:52ml R2:52ml2 refs98/79 R1:54ml R2:54ml98/79 R1:55ml R2:330ml98/79 R1:55ml R2:5*5ml98/79	– 98/79	info@steellex.com EUDAMED record Report an error
Wiener Laboratorios SAIC EU representative : Medical Technology Promedt Consulting GmbH (Germany)	Argentina	APTT ellagic2 refs98/79 APTTest ellágico98/79 Coagulation Calibrator2 refs98/79 Control Plasma Normal98/79 Control Plasma Pathologic98/79 18 others Fibrinogen98/79 Fibrinógeno98/79 Plasma Control Normal98/79 Prothrombin Time98/79 Prothrombin Time plus2 refs98/79 Soluplastin3 refs98/79 Thrombin Time98/79 Anticoagulante TP (no longer marketed) APTTest98/79 (no longer marketed) Chrom ATIII98/79 (no longer marketed) Chrom Protein C98/79 (no longer marketed) Coagulation Control N98/79 (no longer marketed) Coagulation Control P98/79 (no longer marketed) Factor IX Deficient Plasma98/79 (no longer marketed) Factor VIII Deficient Plasma98/79 (no longer marketed) Imidazole buffer (no longer marketed) Plasma Control Patológico98/79 (no longer marketed) Tiempo de Trombina98/79 (no longer marketed)	A IVDR, 98/79	Website marketing@wiener-lab.com EUDAMED record Report an error
Fortress Diagnostics	Northern Ireland	APTT Reagent with Calcium Chloride (Liquid Stable) COAG110A98/79 D-Dimer Control (Level I) COAG134A98/79 D-Dimer Control (Level II) COAG135A98/79 D-Dimer Latex Kit COAG115D98/79 D-Dimer Latex Kit COAG115E98/79 7 others FACTOR V Assay Kit COAG128B98/79 FACTOR XI Assay Kit COAG133B98/79 Fibrinogen (L.S) Immunoturbidimetric, Multipoint BXC0442A98/79 Plasma Control Level I & II (COAG112A)98/79 Plasma Control Level I COAG108A98/79 Plasma Control Level II COAG109A98/79 PT High Sensitivity (Liquid Stable) ISI ~1.15 COAG101C98/79	– 98/79	Website info@fortressdiagnostics.com EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	APTT Reagent98/79 APTT Reagent (SP-UNICELIN)2 refs98/79 D-Dimer Turbi Latex7 refs98/79 FIBRINOGEN98/79 FIBRINOGEN Immuno - Turbidimetry98/79 6 others FIBRINOGEN-LS Clauss Clotting Time Method2 refs98/79 Plasma control set For coagulation Assays98/79 PT Reagent (SP-Normoplastin)2 refs98/79 PT Reagent ISI 1.052 refs98/79 PT Reagent ISI 1.52 refs98/79 Recoplastin ISI 1.0 PT Reagent4 refs98/79	– 98/79	Website EUDAMED record Report an error
Spinreact	Spain	APTT No98/79 ATHROM-III NO6 refs98/79 COAGULATION CAL No98/79 COAGULATION CONTROL N No98/79 COAGULATION CONTROL P No98/79 6 others D-DIMER98/79 D-DIMER CAL 098/79 D-DIMER CONTROL 098/79 D-DIMER MD170923198/79 FIBRINOGEN2 refs98/79 PT No5 refs98/79	– 98/79	Website EUDAMED record Report an error
Tosoh EU representative : Tosoh Europe N.V. (Belgium)	Japan	AIA-PACK D-Dimer CONTROL SET98/79 AIA-PACK Homocysteine CONTROL SET98/79 CL AIA-PACK D-Dimer ADJUSTER SET98/79 CL AIA-PACK D-Dimer TEST CUP98/79 ST AIA-PACK D-Dimer98/79 6 others ST AIA-PACK D-Dimer CALIBRATOR SET98/79 ST AIA-PACK D-Dimer SAMPLE DILUTING SOLUTION98/79 ST AIA-PACK Homocysteine98/79 ST AIA-PACK Homocysteine CALIBRATOR SET98/79 ST AIA-PACK Homocysteine PRETREATMENT SET98/79 ST AIA-PACK Homocysteine SAMPLE DILUTING SOLUTION98/79	– 98/79	csc@tosoh.co.jp EUDAMED record Report an error
Wondfo EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Activated Clotting Time (Non-anticoagulant) Reagent Kit (Clotting) W483P000798/79 Activated Clotting Time Reagent Kit (Clotting) W48398/79 Activated Partial Thromboplastin Time Reagent Kit (Clotting) W48198/79 Coagulation Control W86398/79 Fibrinogen Reagent Kit (Clotting) W48298/79 6 others Finecare3 refs98/79 Prothrombin Time Reagent Kit (Clotting) W48098/79 SmarLumi12 refs98/79 SmarLumi Plasmin-α2-Antiplasmin Complex (CLIA)4 refs98/79 SmarLumi Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)4 refs98/79 Thrombin Time Reagent Kit (Clotting) W48498/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Illumaxbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Assay Kit(Chemiluminescent Immunoassay) 24 strips/box98/79 D-Dimer Assay Kit(Chemiluminescent Immunoassay) 48 strips/box98/79 Fibrinogen Degradation Products Assay Kit (Chemiluminescent Immunoassay) 24 strips/box98/79 Fibrinogen Degradation Products Assay Kit (Chemiluminescent Immunoassay) 48 strips/box98/79 Plasmin-α2 Plasmin inhibitor Complex Assay Kit (Chemiluminescent Immunoassay) 24 strips/box98/79 5 others Plasmin-α2 Plasmin inhibitor Complex Assay Kit (Chemiluminescent Immunoassay) 48 strips/box98/79 Thrombin-Antithrombin Ⅲ Complex Assay Kit (Chemiluminescent Immunoassay) 24 strips/box98/79 Thrombin-Antithrombin Ⅲ Complex Assay Kit (Chemiluminescent Immunoassay) 48 strips/box98/79 tissue Plasminogen Activator-plasminogenactivator Inhibitor-1 Complex Complex Assay Kit (Chemiluminescent Immunoassay) 24 strips/box98/79 tissue Plasminogen Activator-plasminogenactivator Inhibitor-1 Complex Complex Assay Kit (Chemiluminescent Immunoassay) 48 strips/box98/79	– 98/79	Website EUDAMED record Report an error
Micropointbio EU representative : Obelis s.a. (Belgium)	China	mLabs® D-Dimer M101-09100198/79 qLabs® APTT Liquid Control QS-9-CL Pro98/79 qLabs® APTT Test Strips QS-9 Pro98/79 qLabs® Coag Panel 2 Liquid Control QS-4-CL Pro98/79 qLabs® FIB Controls Level 1 QS-18-CLN98/79 5 others qLabs® FIB Controls Level 2 QS-18-CLP98/79 qLabs® Multi-level Coag Controls QS-6-CL Pro98/79 qLabs® PT-INR Liquid Control QS-1-CL Pro98/79 qLabs® PT-INR Owren (Dry) Test Strips QS-298/79 qLabs® PT-INR Owren (Dry) Test Strips QS-2 Pro98/79	– 98/79	Website EUDAMED record Report an error
Mindray EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Activated Partial Thromboplastin Time (APTT) Assay Kit (Clotting Method) 105-023616-00、105-023617-00、105-023618-003 refs Antithrombin III (AT Ⅲ) Assay Kit (Chromogenic Substrate Method) 105-023634-00、105-023635-00、105-023636-00、105-023637-00、105-023640-00、105-023641-003 refs Coagulation Control 105-023642-00、105-023643-002 refs D-Dimer (CLIA) 105-046778-00, 105-046779-003 refs D-Dimer Assay Kit (Immunoturbidimetry Method) 105-023628-00、105-023629-00、105-023630-00、105-023647-00、105-024608-00、105-024609-00、105-024610-003 refs 5 others Fibrin(ogen) Degradation Products (FDP) Assay Kit (lmmunoturbidimetry Method) 105-023631-00、105-023632-00、105-023633-00、105-023648-00、105-023644-00、105-023645-00、105-023646-003 refs Fibrinogen (FIB) Assay Kit (Clotting Method) 105-023622-00、105-023623-00、105-023624-00、105-023625-00、105-023626-00、105-023627-003 refs HCY Control 105-009174-00、105-009175-00、105-009176-00、105-009194-003 refs Prothrombin Time (PT) Assay Kit (Clotting Method) 105-023613-00、105-023614-00、105-023615-003 refs Thrombin Time (TT) Assay Kit (Clotting Method) 105-023619-00、105-023620-00、105-023621-003 refs	B, C IVDR	Website EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Hemolumi APTT (Clotting Assay)10 refs98/79 Hemolumi AT III (Chromogenic Substrate Assay)10 refs98/79 Hemolumi Coagulation Calibrators4 refs98/79 Hemolumi D-Dimer (Latex)8 refs98/79 Hemolumi D-Dimer Calibrators4 refs98/79 5 others Hemolumi FDP (Latex)8 refs98/79 Hemolumi FDP Calibrators4 refs98/79 Hemolumi Fibrinogen (Clotting Assay)10 refs98/79 Hemolumi PT (Clotting Assay)10 refs98/79 Hemolumi TT (Clotting Assay)10 refs98/79	– 98/79	Website EUDAMED record Report an error
Aidian	Finland	Protein Calibrator Set98/79 Protein Control98/79 QuikRead CRP Control98/79 QuikRead go CRP Control98/79 QuikRead go CRP Control Low98/79 4 others QuikRead go CRP Control Set98/79 QuikRead go HbA1c98/79 QuikRead go HbA1c Control Set98/79 Urine Albumin Control98/79	– 98/79	Website eudamed@aidian.eu EUDAMED record Report an error
Getein EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Fast Test Kit (Immunofluorescence Assay)9 refs D-Dimer Reagent Kit (Immunoturbidimetric Method)98/79 MAGICL D-Dimer (CLIA)98/79 MAGICL DD (CLIA)98/79 MAGICL FDP (CLIA)98/79 4 others MAGICL PIC (CLIA)2 refs98/79 MAGICL t-PAIC (CLIA)2 refs98/79 MAGICL TAT (CLIA)2 refs98/79 MAGICL TM (CLIA)2 refs98/79	C IVDR, 98/79	EUDAMED record Report an error
Biosystems	Spain	ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)3 refs98/79 ANTI-PHOSPHOLIPID IgG/IgM (APLA)98/79 D-DIMER2 refs98/79 D-DIMER CONTROLS I / II98/79 D-DIMER STANDARD98/79 3 others FIBRINOGEN3 refs98/79 FIBRINOGEN CONTROL PLASMA98/79 FIBRINOGEN STANDARD98/79	– 98/79	Website EUDAMED record Report an error
Hangzhou Alltest Biotech EU representative : MedNet EC-REP GmbH (Germany)	China	D-dimer Rapid Test Cassette (WB / P)98/79 D-dimer Rapid Test Cassette CDM-40298/79 D-dimer Rapid Test Cassette CDM-R40298/79 D-dimer Rapid Test Cassette CDM-R402SQ98/79 D-Dimer Test Cassette (Whole Blood/Plasma) FI-DDM-40298/79 3 others D-Dimer Test Cassette FI-DDM-40298/79 D-Dimer Test Cassette(WB/P)98/79 D-Dimer Test Kit (CLIA)98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Linear	Spain	APTT98/79 Clonatest2 refs98/79 Cromatest10 refs98/79 Cromatest Plasma Control Level 12 refs98/79 Cromatest Plasma Control Level 22 refs98/79 3 others Cromatetst98/79 Fibrinogen98/79 PT-HS98/79	– 98/79	Website info@linear.es EUDAMED record Report an error
Pentapharm EU representative : Emergo Europe B.V. (Netherlands)	Switzerland	APCr APCr Controls Batroxobin Time Pefaclot® UFH Controls98/79 Pefaclot® UFH98/79 3 others Pefakit® APC-R Factor V Leiden Controls98/79 Pefakit® APC-R Faktor V Leiden98/79 Pefakit® Reptilase® Time98/79	B IVDR, 98/79	Website RA@pentapharm.com EUDAMED record Report an error
Shenzhen Superbio Technology EU representative : QbD RepS BV (Belgium)	China	CLIA FDP Control98/79 D-Dimer Assay Kit CLIA2 refs98/79 Diagnostic Kit for D-Dimer (DD) (Time-resolved Fluorescence Immunochromatographic Assay)98/79 FDP Assay kit CLIA2 refs98/79 HCY Assay kit CLIA2 refs98/79 3 others PIC Assay kit CLIA2 refs98/79 TAT Assay kit CLIA2 refs98/79 tPAIC Assay kit CLIA2 refs98/79	– 98/79	info@sup-bio.com EUDAMED record Report an error
Xenta Biomedical Science EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Detection Kit (Fluorescent Immune Chromatography)2 refs98/79 D-Dimer Rapid Quantitative Test XRDL007A105OS98/79 D-Dimer Rapid Quantitative Test XRDL007A120OS98/79 Fibrin and Fibrinogen Degradation Products (FDP) Rapid Quantitative Test2 refs98/79 Plasmin-α2-Plasmin Inhibitor Complex (PIC) Rapid Quantitative Test2 refs98/79 3 others Plasminogen (PLG) Rapid Quantitative Test2 refs98/79 Thrombin-Antithrombin Ⅲ Complex (TAT) Rapid Quantitative Test2 refs98/79 Tissue-Type Plasminogen Activator Inhibitor-1 Complex (t-PAIC) Rapid Quantitative Test2 refs98/79	– 98/79	Website EUDAMED record Report an error
Genrui Biotech EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	225 tests98/79 25 tests98/79 50T/Kit98/79 D-Dimer Detection Kit (Nephelometry)98/79 D-Dimer Detection Kit (Nephelometry) 225 tests98/79 2 others D-Dimer Detection Kit (Nephelometry) 25 tests98/79 D-Dimer test kit (Immunofluorescence) 25T/kit98/79	– 98/79	Website service@genrui-bio.com EUDAMED record Report an error
Goldsite EU representative : CMC Medical Devices & Drugs SL (Spain)	China	FIA Go D-Dimer Kit98/79 GPP-100 D-Dimer Kit98/79 Kemilo D-Dimer Kit98/79 Nephstar AT3 Kit98/79 Nephstar D-Dimer Kit98/79 2 others Omlipo AT3 Kit98/79 Omlipo D-Dimer Kit98/79	– 98/79	Website export@goldsite.com.cn EUDAMED record Report an error
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇	Türkiye	D-Dimer 77 mL98/79 D-DIMER Kit 40mL98/79 D-Dimer Kit 52mL98/79 D-DIMER Kit 82mL98/79 D-DIMER Kit B3344798/79 2 others D-Dimer Reagent Kit K4444798/79 D-DIMER Reagent Kit K4644798/79	– 98/79	info@kinetikkimya.com EUDAMED record Report an error
Quimica Clinica Aplicada	Spain	ANTITROMBINA III98/79 CALIBRADOR DE COAGULACIÓN98/79 CITRATO SODICO 3.2%3 refs CONTROLES DE COAGULACIÓN98/79 FIBRINÓGENO98/79 2 others HEMOSCANN®2 refs98/79 PLASMASCANN® LIQUIDO2 refs98/79	A IVDR, 98/79	Website EUDAMED record Report an error
Seekxbio EU representative : GRZAN GROUP SL (Spain)	China	Activated Clotting Time Cartridge(ACT) CK20133 refs98/79 Coagulation Panel Cartridge CK20013 refs98/79 Coagulation Panel Cartridge CK20023 refs98/79 Coagulation Panel Cartridge CK20033 refs98/79 Coagulation Panel Cartridge CK20043 refs98/79 2 others NeoCoag Coagulation Test Strip Neo1013 refs98/79 NeoCoag Coagulation Test Strip Neo1023 refs98/79	– 98/79	EUDAMED record Report an error
Abbott EU representative : Emergo Europe B.V. (Netherlands)	United States	i-STAT ACT Control Level 1 06P17-1598/79 i-STAT ACT Control Level 2 06P17-1698/79 i-STAT Celite ACT Cartridge 03P86-2598/79 i-STAT Kaolin ACT Cartridge98/79 i-STAT PTplus cartridge 03P89-50 1 other i-STAT PTplus Control Level 1 06P17-172 refs	C IVDR, 98/79	EUDAMED record Report an error
Aichek EU representative : Medunion S.L. (Spain) and 1 other	China	D-Dimer Rapid Test D-D-D02a98/79 D-Dimer (CLIA)98/79 D-Dimer Test Kit FIA98/79 PIC Plasmin-α2-Plasmin Inhibitor Complex (CLIA)98/79 TAT Thrombin-Antithrombin III Complex (CLIA)98/79 1 other tPAI·C Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (CLIA)98/79	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Atlas Medical	Germany	Atlas Activated Partial Thromboplastin Time (APTT) Reagent, 2 ml /Vial, 1 Vial/Box. 8.02.41.1.004098/79 Atlas Activated Partial Thromboplastin Time (APTT) Reagent, 2x2 ml APTT reagent, 1x1 ml Normal Control, 3 Vials /Box. 8.02.45.0.008098/79 Atlas D-Dimer Latex Kit, 25 Tests 8.00.17.0.002598/79 Atlas D-Dimer Latex, 100 Tests 8.00.17.0.010098/79 Atlas D-Dimer Latex, 50 Tests 8.00.17.0.005098/79 1 other Atlas SLE Latex , 50 Tests 8.00.11.0.005098/79	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
Biokit	Spain	D-Dimer 01R10013 refs HemosIL AcuStar VWF:CB 0009802044 HemosIL FDP3 refs HemosIL HIT- Ab(PF4-H) Controls2 refs HemosIL VWF:RCo 0020300900 1 other Quantia D-Dimer3 refs	B, C IVDR	EUDAMED record Report an error
Chronolab	Spain	APTT, R1 5 x 4 mL, R2 5 x 4 mL98/79 Coagulation calibrator, 4 x 1 mL98/79 Coagulation control N, 4 x 1 mL98/79 Coagulation control P, 4 x 1 mL98/79 Fibrinogen, R1 8 x 2 mL, R2 1 x 100 mL, R3 1 x 3.5 mL98/79 1 other Prothrombin Time, 4 x 4 mL98/79	– 98/79	Website info@chronolab.com EUDAMED record Report an error
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer (DD) Assay Reagent Kit (CMIA) C2KD00198/79 D-Dimer (DD) Rapid Test Device (Whole blood/Plasma） E051001D98/79 D-Dimer (DD) Rapid Test Device (Plasma) E061101D98/79 D-Dimer Rapid Test Device (Plasma) E041101D98/79 D-Dimer Rapid Test Device (whole blood/plasma) E011001D98/79 1 other D-Dimer Rapid Test Device(Colloidal Gold) E030501D98/79	– 98/79	info@cybereagen.com EUDAMED record Report an error
Guangzhou KOFA Biotechnology EU representative : Medunion S.L. (Spain)	China	D-Dimer CLIA8 refs98/79 D-Dimer Immunofluorescence Assay6 refs98/79 FDP CLIA8 refs98/79 PIC CLIA8 refs98/79 t-PAIC CLIA7 refs98/79 1 other TAT CLIA8 refs98/79	– 98/79	EUDAMED record Report an error
Iline Microsystems	Spain	microINR Chips CHB0025AA98/79 microINR Chips CHB0025AB98/79 microINR Chips CHB0025AB-1098/79 microINR Chips CHB0025AC98/79 microINR Chips CHB0025AU98/79 1 other microINR EasyControl EKA0005UU98/79	– 98/79	eudamed@ilinemicrosystems.com EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-dimer Rapid Test Kit (QDs Immunofluorescence Method) D-dimer-QD98/79 D-Dimer Test Kit (CLIA Method)98/79 Fibrinogen Degradation Product (FDP) Test Kit (CLIA Method)98/79 Plasmin-α2-Plasmin Inhibitor Complex (PIC) Test Kit (CLIA Method)98/79 Thrombin-Antithrombin Ⅲ complex (TAT) Test Kit (CLIA Method)98/79 1 other Tissue Plasminogen Activator-Plasminogen Activator Inhibitor-1 Complex (tPAIC) Test Kit (CLIA Method)98/79	– 98/79	Website EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	APTT Activated Partial Thromboplastin Time Test Kit98/79 D-Dimer Test Kit Ir08798/79 FIB Fibrinogen Test Kit98/79 PT Prothrombin Time Test Kit98/79 PT/APTT Test Panel98/79 1 other TT Thrombin Time Test Kit98/79	– 98/79	EUDAMED record Report an error
Nanjing Norman Biological Technology EU representative : Sungo Cert GmbH (Germany)	China	D-Dimer Test Kit (Chemiluminescence) 100tests/box98/79 D-Dimer Test Kit (Chemiluminescence) 50tests/box98/79 D-Dimer Test Kit (Chemiluminescence) 50×2tests/box98/79 D-Dimer Test Kit (Immunofluorescence) 25 Tests /Box98/79 D-Dimer Test Kit (Immunoturbidimetry) 50tests/box98/79 1 other Fibrin (proto) Degradation Product (FDP) Test Kit (Immunofluorescence) 25 Tests /Box98/79	– 98/79	EUDAMED record Report an error
Realmindbio EU representative : Lotus NL B.V. (Netherlands)	China	Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit98/79 Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit5 refs98/79 Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit98/79 Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit98/79 Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit98/79 1 other Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit98/79	– 98/79	EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	D-Dimer Detection Kit(CLIA) 50 Tests/kit98/79 D-dimer Detection Kit(Fluorescence Immunoassay) 25 Tests/kit98/79 Fibrin/Fibrinogen Degradation Products(FDP) Detection Kit(CLIA) 50 Tests/kit98/79 Thrombin-Antithrombin Complex(TAT) Detection Kit(CLIA) 50 Tests/kit98/79 Tissue plasminogen activator-Plasminogen activator inhibitor Complex(t-PAIC) Detection Kit(CLIA) 50 Tests/kit98/79 1 other α2-plasmininhibitor-Plasmin Complex(PIC) Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Vazyme EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CC98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CL98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2402CV98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2403CC98/79 D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2403CV98/79 1 other D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography) D2404CC98/79	– 98/79	EUDAMED record Report an error
Acro Biotech EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	D-dimer Rapid Test Cassette (Whole Blood /Plasma) CDM-R402SQ98/79 D-dimer Rapid Test Cassette (Whole Blood/Plasma) CDM-40298/79 D-dimer Rapid Test Cassette DDM2D98/79 D-Dimer Test Cassette (Whole Blood /Plasma) ACO-DDM-40298/79 D-Dimer Test Kit(CLIA)98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Boditech EU representative : Obelis s.a. (Belgium)	South Korea	AFIAS D-Dimer98/79 AFIAS D-Dimer Neo98/79 EZ POC D-Dimer98/79 ichroma™ D-Dimer98/79 ichroma™ D-Dimer Neo98/79	– 98/79	Website marketing@boditech.co.kr EUDAMED record Report an error
Bosonbio EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	D-Dimer assay (CLIA)98/79 D-Dimer Test (FIA)98/79 PIC assay (CLIA)98/79 Rapid D-Dimer Test Card 1M21C298/79 Thrombin-Antithrombin III Complex assay (CLIA)98/79	– 98/79	Website EUDAMED record Report an error
C-Luminary Biotechnology EU representative : Sungo Cert GmbH (Germany)	China	Sharay D-Dimer(CLIA)98/79 Sharay FDP (CLIA)98/79 Sharay PIC (CLIA)98/79 Sharay t-PAIC (CLIA)98/79 Sharay TAT (CLIA)98/79	– 98/79	EUDAMED record Report an error
Diagnostics	Belgium	APTT (Act. Thromboplastine Time) HC0010098/79 Calibrator Fibr/PT HC0060098/79 Coagulation Control HC0050098/79 Fibrinogen HC0030098/79 PT Prothrombin Time HC0020098/79	– 98/79	Website EUDAMED record Report an error
Eurolyser	Austria	D-Dimer control kit ST150098/79 D-Dimer test kit (16 tests)98/79 D-Dimer test kit (6 tests)98/79 PT (INR) control kit98/79 PT (INR) test kit (32 tests)98/79	– 98/79	Website EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany)	Egypt	D-Dimer Turbi Latex98/79 Fibrinogen-LS Clauss Clotting Time Method98/79 Liquid PT Reagent ISI 1.03 refs98/79 PT Reagent ISI 1.53 refs98/79 PTT Reagent98/79	– 98/79	EUDAMED record Report an error
Milenia Biotec	Germany	Milenia QuickLine HIT Control98/79 Milenia QuickLine HIT STic EXPERT HIT 2098/79 STic Expert HIT 598/79 STic EXPERT HIT 5/2098/79 STic Expert HIT Control98/79	– 98/79	Website info@milenia-biotec.de EUDAMED record Report an error
Pro-med (Beijing) Technology EU representative : Sungo Cert GmbH (Germany)	China	1 test/kit98/79 10 tests/kit98/79 25 tests/kit98/79 5 tests/kit98/79 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Sansure EU representative : Obelis s.a. (Belgium)	China	D-Dimer Assay Kit (Chemiluminescent Immunoassay)2 refs98/79 D-Dimer Chemiluminescence Immunoassay Kit6 refs98/79 Fibrin/fibrinogen Degradation Products Chemiluminescence Immunoassay Kit6 refs98/79 Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit6 refs98/79 Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemiluminescence Immunoassay Kit6 refs98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	D-Dimer（CLIA)8 refs98/79 FDP (CLIA)12 refs98/79 PIC (CLIA)12 refs98/79 TAT(CLIA)12 refs98/79 TM-7 (CLIA)12 refs98/79	– 98/79	Website sales@tellgen.com EUDAMED record Report an error
Bgi	Denmark	BGI 10 tests/kit98/79 BGI 25 tests/kit98/79 BGI 5 tests/kit98/79 BGI 50 tests/kit98/79	– 98/79	Website EUDAMED record Report an error
Fisher Diagnostics A division of Fisher Scientific EU representative : B·R·A·H·M·S GmbH (Germany)	United States	100356, J10035698/79 100402, J10040298/79 100403, J10040398/79 100607, J10060798/79	– 98/79	Website EUDAMED record Report an error
Healgen EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	D-Dimer Control FDDDI-PN2098/79 D-Dimer Quantitative Test Kit (Time-Resolved FIA) FDDDI-402a98/79 D-Dimer Rapid Test Cassette (Whole Blood/Plasma) GDDDI-402b98/79 D-Dimer Test Kit (CLIA)98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Immucor EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany)	United States	PF4 Concentrated Wash 403624 PF4 Enhanced X-HAT132 refs PF4 IgG HAT13G2 refs Specimen Diluent 403602	A, C IVDR	EUDAMED record Report an error
Jiangxi Medicalsystem Biological Technology EU representative : Medunion S.L. (Spain)	China	D-Dimer Kit（CLIA） 100T98/79 D-Dimer Kit（CLIA） 50T98/79 Fibrinogen Degradation Product Kit（CLIA） 100T98/79 Fibrinogen Degradation Product Kit（CLIA） 50T98/79	– 98/79	EUDAMED record Report an error
Kamiya Biomedical EU representative : Advena Limited (Malta)	United States	Coagulation Control K204C-10M3 refs K-ASSAY Factor XIII Calibrator KAI-106C98/79 K-ASSAY Factor XIII Control K135C-10M98/79 K-ASSAY Factor XIII KAI-10598/79	B IVDR, 98/79	Website info@k-assay.com EUDAMED record Report an error
MedicalSystem Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Control 1×0.5mL98/79 D-Dimer Kit (Latex-Enhanced Immunoturbidimetric Method) 48mL（R1:1×36mL+R2:1×12mL）98/79 Fibrinogen Degradation Product Kit (Latex-Enhanced Immunoturbidimetric Method) 48ml（R1:1×36ml+R2:1×12ml）98/79 Fibrinogen Kit (Immunoturbidimetric Method) 60ml（R1:1×45ml+R2:1×15ml）98/79	– 98/79	EUDAMED record Report an error
Monobind EU representative : AR Experts B.V. (Netherlands)	United States	D-Dimer AccuBind ELISA Kit - 192 wells 12025-300B98/79 D-Dimer AccuBind ELISA Kit - 96 wells 12025-300A98/79 D-Dimer AccuLite CLIA Kit - 192 wells 12075-300B98/79 D-Dimer AccuLite CLIA Kit - 96 wells 12075-300A98/79	– 98/79	Website info@monobind.com EUDAMED record Report an error
nal von minden	Germany	Hitado D-Dimer Test2 refs98/79 meditrol® D-Dimer Test5 refs98/79 NADAL® D-Dimer Test5 refs98/79 S-MedPro D-Dimer Test98/79	– 98/79	Website info@nal-vonminden.com EUDAMED record Report an error
Orientgene EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Control FDDDI-PN2098/79 D-Dimer Quantitative Test Kit (Time-Resolved FIA) FDDDI-402a98/79 D-Dimer Rapid Test Cassette (Whole Blood/Plasma) GDDDI-402b98/79 FDDDI-402a-DR10/FDDDI-402a-DR/FDDDI-402a-DR10LH/FDDDI-402a-DRLH/FDDDI-402a-DR10HG/FDDDI-402a-DRHG3 refs	C IVDR, 98/79	EUDAMED record Report an error
Shenzhen Dake Medical Technology EU representative : HyperCert Limited B.V. (Netherlands)	China	D-Dimer Assay kit Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs Thrombin-antithrombin Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method） 25 tests，50 tests，2×50 tests，100 tests，2×100 tests3 refs	B, C IVDR	EUDAMED record Report an error
Shenzhen Yhlo Biotech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	iFlash-D-dimer2 refs iFlash-FDP2 refs iFlash-PIC2 refs iFlash-TAT2 refs	C IVDR	Website info@szyhlo.com EUDAMED record Report an error
Sichuan Orienter Biotechnology EU representative : Medunion S.L. (Spain)	China	D-Dimer (D-D) Assay Kit (Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Fibrin Degradation Products (FDP) Assay Kit (Chemiluminescent Immunoassay) /2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 t-PAIC Assay Kit(Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79 Thrombin-Antithrombin Ⅲ complex(TAT) Assay Kit(Chemiluminescent Immunoassay) 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×298/79	– 98/79	Website info@orienterglobal.com EUDAMED record Report an error
Thermofisher	Finland	D-Dimer D-Dimer Calibration Set D-Dimer Control D-Dimer Control High	C IVDR	Website EUDAMED record Report an error
Vitrosens	Türkiye	PCPO07-01 RapidFor™3 refs RapidFor™ VMD56BDLA98/79 RapidFor™ VMPO08ED98/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	D-Dimer Chemiluminescence Immunoassay Test Kit98/79 D-Dimer FIA DDM-W23F398/79 Device A1061011	C IVDR, 98/79	Website contact@diareagent.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain)	China	D-Dimer (DD) Rapid Quantitative Test Kit (Immunofluorescence Assay) 1 Test/Kit98/79 D-Dimer (DD) Rapid Quantitative Test Kit (Immunofluorescence Assay) 25 Tests/Kit98/79 D-Dimer (DD) Rapid Quantitative Test Kit (Immunofluorescence Assay) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
CoaguSense EU representative : Emergo Europe B.V. (Netherlands)	United States	Coag-Sense Control Test Strip Kit - 10 Count 03P69-1098/79 Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit 10021898/79 Coag-Sense Prothrombin Time (PT)/INR Test Strip Kit 20020998/79	– 98/79	Website EUDAMED record Report an error
Denizbiyokimya	Türkiye	INNOVIQURE D-dimer Reagent Kit 100T98/79 INNOVIQURE D-dimer Reagent Kit 200T98/79 INNOVIQURE D-dimer Reagent Kit 400T98/79	– 98/79	EUDAMED record Report an error
Diagon	Hungary	Dia-CaCl22 refs Dia-IMIDAZOL Dia-PT 1098/79	A IVDR, 98/79	Website EUDAMED record Report an error
Dialab	Austria	Abnormal Coagulation Control Plasma T95510198/79 Antithrombin III 5+16 refs98/79 Antithrombin III A0051098/79	– 98/79	Website office@dialab.at EUDAMED record Report an error
Diazyme EU representative : MDSS GmbH (Germany)	United States	Diazyme D-Dimer Assay2 refs98/79 Diazyme D-Dimer Calibrator Set98/79 Diazyme D-Dimer Control Set98/79	– 98/79	Website EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Rapid Test 1Test/Kit98/79 D-Dimer Rapid Test 25Tests/Kit98/79 Filariasis IgG/IgM Rapid Test 25Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
Giesse Diagnostics	Italy	Antitrombina III 670498/79 D-Dimero 673798/79 Fibrinogeno 780498/79	– 98/79	Website info@giessediagnostics.com EUDAMED record Report an error
Hemonart	Türkiye	BlacT ACT Test Tube98/79 PlacT ACT Test Tube98/79 Whole Blood Quality Controls98/79	– 98/79	Website info@hemonart.com EUDAMED record Report an error
Lansionbio EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Test Kit (Dry Fluorescence Immunoassay)98/79 FDP Test Kit (Dry Fluorescence Immunoassay)98/79 HCY Test Kit (Dry Fluorescence Immunoassay)98/79	– 98/79	EUDAMED record Report an error
Medical & Biological Laboratories EU representative : QbD RepS BV (Belgium)	Japan	HEXAMATE Factor XIII HEXAMATE Factor XIII - Calibrator HEXAMATE Factor XIII – Control I/II	B IVDR	EUDAMED record Report an error
Nihon Kohden EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	Japan	"D-dimer Calibrator DD-CAL" "D-dimer Control DD-QC" Celltac chemi D-dimer DD-421W	C IVDR	Website information@db.nkc.co.jp EUDAMED record Report an error
Precision BioLogic EU representative : Emergo Europe B.V. (Netherlands)	Canada	CRYOcheck26 refs CRYOcheck Abnormal 1 Reference Control2 refs CRYOcheck Abnormal 2 Reference Control	C IVDR	EUDAMED record Report an error
Pushkang EU representative : Sungo Cert GmbH (Germany)	China	150tests98/79 1ml*102 refs98/79 60 tests98/79	– 98/79	EUDAMED record Report an error
Sysmex EU representative : Sysmex Europe SE (Germany)	Japan	HISCL HIT IgG Assay Kit HISCL HIT IgG Calibrator HISCL HIT IgG Control	C IVDR	ra_archive@sysmex.co.jp EUDAMED record Report an error
Vellap	Germany	Cleartest D-Dimer98/79 TOP D-Dimer C3 0501-5-MTU98/79 VELLAP D-Dimer3 refs	C IVDR, 98/79	info@vellap.de EUDAMED record Report an error
Vivachek EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Rapid Test VCDI98/79 D-Dimer Test Kit (FIA) VID1198/79 Des-Gamma-Carboxy Prothrombin Test Kit (FIA) VID13698/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : SUNGO Europe B.V. (Netherlands)	China	D-Dimer Assay Kit (Chemiluminescent Immunoassay) 100 Tests/Kit98/79 D-Dimer Assay Kit (Chemiluminescent Immunoassay) 25 Tests/Kit98/79 D-Dimer Assay Kit (Chemiluminescent Immunoassay) 50 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Sinocare EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Reagent Kit 2N00198/79 Prothrombin Time Reagent Kit 1S00198/79 Sinocare98/79 (no longer marketed)	– 98/79	RA@sinocare.com EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany)	China	Accu-Tell® D-Dimer Cassette (Whole Blood/Plasma/Serum)98/79 Accu-Tell® D-Dimer Strip (Whole Blood/Plasma/Serum)98/79	– 98/79	sales@accubiotech.com EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	FIAflex98/79 Flowflex98/79	– 98/79	Website EUDAMED record Report an error
Aehealth EU representative : MedNet EC-REP GmbH (Germany)	China	1 test/kit, 5 tests/kit, 10 tests/kit, 20 tests/kit, 25 tests/kit, 30 tests/kit, 50 tests/kit, 100 tests/kit.98/79 2 x 1 x 0.6 mL98/79	– 98/79	sales@aehealth.com.cn EUDAMED record Report an error
Apiro	Hungary	QC1 2011EU QC2 2021EU	C IVDR	Website info@apiro.eu EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	D-Dimer rapid test cassette (Rare earth nano fluorescence immunochromatography)98/79 Fibrinogen/Fibrin Degradation Products (PDF) rapid test cassette (Rare earth nano fluorescence immunochromatography)98/79	– 98/79	EUDAMED record Report an error
Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)	China	COX-1 Platelet Aggregation Test Reagent Card (Turbidimetry) 10 tests/kit98/79 P2Y12 Receptor Platelet Aggregation Test Reagent Card (Turbidimetry) 10 tests/kit98/79	– 98/79	EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruHemo7 refs98/79 TruVue98/79	– 98/79	EUDAMED record Report an error
Biohermes EU representative : CMC Medical Devices & Drugs SL (Spain)	China	BF C063 refs98/79 BF S065 refs98/79	– 98/79	EUDAMED record Report an error
bioMérieux	France	VIDAS® D-Dimer Exclusion II™3 refs VIDAS® vWF98/79	C IVDR, 98/79	EUDAMED record Report an error
Biotecnica	Italy	ANTITHROMBIN III TURB 61098/79 HOMOCYSTEINE 55398/79	– 98/79	EUDAMED record Report an error
C.P.M. Compagnia Per La Medicina	Italy	D-DIMER I02276/398/79 Fibrinogen‐ONE I021798/79	– 98/79	Website EUDAMED record Report an error
Clongene EU representative : HUMISS TRADING S. L. (Spain) and 1 other	China	D-Dimer FIA CfDDg00298/79 D-Dimer Rapid Test CDDg00298/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
Coei Biotech EU representative : Medunion S.L. (Spain)	China	D-Dimer Rapid Quantitative Test 25 servings/box98/79 hsCRP Rapid Quantitative Test 25 servings/box98/79	– 98/79	EUDAMED record Report an error
Diagreat EU representative : MedNet EC-REP GmbH (Germany)	China	D-Dimer CLIA Kit (Chemiluminescence Immunoassay) 100 tests/box D-Dimer Determination Kit (Fluorescence Immunochromatographic Assay) 25 tests	B IVDR	Website info@diagreat.com EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	1 test/kit98/79 25 tests/kit98/79	– 98/79	info@genesignbio.com EUDAMED record Report an error
HangZhou Biotest Biotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	Rightsign CDIM-C4198/79 Rightsign MCDIM-LC4198/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Hightopbio EU representative : MedNet EC-REP GmbH (Germany)	China	Card type98/79 D-dimer Reagent Kit (Microparticles Chemiluminescent Immunoassay)98/79	– 98/79	Website EUDAMED record Report an error
Hunan AccuBio Biotech EU representative : Sungo Cert GmbH (Germany)	China	100T5 refs98/79 50T5 refs98/79	– 98/79	info@hn-accubio.com EUDAMED record Report an error
Hunan Ehome Health Technology EU representative : Medunion S.L. (Spain)	China	D-Dimer Rapid Test Kit HU-RE-F07F04500198/79 D-Dimer Rapid Test Kit HU-RE-F07F04500298/79	– 98/79	EUDAMED record Report an error
Lysunbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	LYSUN CRP-W21-1(25PCS)98/79 LYSUN DIM-W21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Medconn EU representative : Kingsmead Service B.V. (Netherlands)	China	D-Dimer Reagent Kit 100 Tests/kit98/79 D-Dimer Reagent Kit 50 Tests/kit98/79	– 98/79	EUDAMED record Report an error
MTD Diagnostics	Italy	Antithrombin III Antibody TB116098/79 Homocysteine LS HP98/79	– 98/79	Website EUDAMED record Report an error
Nanjing Leading Medical Technology EU representative : Medunion S.L. (Spain)	China	101.6 mL98/79 50.8 mL98/79	– 98/79	EUDAMED record Report an error
Nanjing Synthgene Medical Technology EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Rapid Test Kit (Colloidal gold method) XJ00298/79 D-Dimer Rapid Test Kit (Quantum Dot Fluorescence Immunoassay) XJ00598/79	– 98/79	Website sales@syngenebio.com EUDAMED record Report an error
Precision Biosensor EU representative : mdi Europa GmbH (Germany)	South Korea	Exdia D-dimer98/79 Exdia D-dimer 298/79	– 98/79	Website info@precision-bio.com EUDAMED record Report an error
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Rapid Test Device (Colloidal Gold) B010216D98/79 D-Dimer Rapid Test Device (Colloidal Gold) B011016D98/79	– 98/79	Website info@realytech.com EUDAMED record Report an error
Shenzhen AmTech Bioengineering EU representative : SUNGO Europe B.V. (Netherlands)	China	100 tests/kit98/79 R1: 2×45 mL, R2: 2×15 mL98/79	– 98/79	EUDAMED record Report an error
Tem Innovations	Germany	ROTROL N 503-2498/79 ROTROL P 503-2598/79	– 98/79	EUDAMED record Report an error
Tisenc EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Tisenc D-Dimer (CLIA)4 refs98/79 Wondfo D-Dimer (CLIA)4 refs98/79	– 98/79	Website EUDAMED record Report an error
Widufit	Germany	D-dimers Rapid Test WIB-DIM-K98/79 WiduMed D-Dimer Test2 refs98/79	– 98/79	Website info@widufit.de EUDAMED record Report an error
Wwhsbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Diagnostic Kit for D-Dimer (Immunochromatographic assay) 20Tests/Kit98/79 Diagnostic Kit for D-Dimer（Immunochromatographic assay） 25Tests/Kit98/79	– 98/79	Website info@wwhsbio.com EUDAMED record Report an error
Yhlo Biotech (Nanjing) EU representative : Medunion S.L. (Spain)	China	Fibrinogen (FIB) Assay Kit (Immunoturbidimetric Method)2 refs98/79 Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)2 refs98/79	– 98/79	EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Rapid Test GCDDM98/79 D-Dimer Test GCDDM98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/Kit98/79 QINGLI Strip: 25Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Responsebio EU representative : Emergo Europe B.V. (Netherlands)	Canada	RAMP D-dimer (C1106)98/79 RAMP Total b-hCG Controls - Level 1 (C4003-1)98/79 (no longer marketed) RAMP Total b-hCG Controls - Level 2 (C4003-2)98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
"Bio-Ksel"	Poland	Bio-Ksel PT plus98/79	– 98/79	Website EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : CEpartner4U (Netherlands)	China	R118-11698/79	– 98/79	EUDAMED record Report an error
Anbio EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Rapid Test Kit A0200800298/79	– 98/79	info@anbio.com EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dime Test98/79	– 98/79	EUDAMED record Report an error
Bensrl	Italy	CALCIUM CHLORIDE VLR01022 refs	A IVDR	Website EUDAMED record Report an error
Biodatacorp EU representative : mdi Europa GmbH (Germany)	United States	Lupus Anticoagulant Confirmation Reagent (LACR)	A IVDR	Website customer.service@biodatacorp.com EUDAMED record Report an error
Bioyuan EU representative : Obelis s.a. (Belgium)	China	Coagulation Control refer to IFU14 refs98/79	– 98/79	ra@bioyuan.cn EUDAMED record Report an error
Cormay	Poland	AURYX 90 D-dimer STAT Reagent Kit2 refs98/79	– 98/79	regulatory_affairs@cormay.com EUDAMED record Report an error
Darui Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	100 tests/kit98/79	– 98/79	EUDAMED record Report an error
Dyonmed	Greece	DyonDimer (D-Dimer)98/79	– 98/79	Website customerservice@dyonmedical.com EUDAMED record Report an error
Guangzhou Decheng Biotechnology EU representative : QbD RepS BV (Belgium)	China	D-Dimer (DD) Rapid Test Kit (Fluorescence Immunochromatographic Assay)98/79	– 98/79	Website service@dochekbio.com EUDAMED record Report an error
Hebei Sanxin Pharmaceutical Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	D-Dimer Fluorescent Immunochromatographic Assay (FIA) Kit 25 tests per box98/79	– 98/79	EUDAMED record Report an error
Helena Biosciences Europe EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Thromboplastin L 5265HL3 refs	C IVDR	Website EUDAMED record Report an error
Helixgen (GUANGZHOU) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	PT/INR test strip98/79	– 98/79	EUDAMED record Report an error
Hotgen EU representative : MedNet EC-REP GmbH (Germany)	China	D-Dimer test (Chemiluminescence Immunoassay) Please see the IFU	C IVDR	service@hotgen.com.cn EUDAMED record Report an error
Hoyotek EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	D-Dimer Rapid Test Kit (Fluorescence Immunochromatographic Assay) Please see the IFU.2 refs98/79	– 98/79	Website inquiry@hoyotek.cn EUDAMED record Report an error
Humadx EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany)	China	25T98/79	– 98/79	service@humadx.com.cn EUDAMED record Report an error
Hunan Kangxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-dimer Kit (Microfluidic Fluorescent Immunoassay)98/79	– 98/79	EUDAMED record Report an error
Huzhou Jierunxin Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	D-Dimer Test (Fluorescence Immunoassay)98/79	– 98/79	EUDAMED record Report an error
IBL International	Germany	Cholin IgG/IgM ELISA98/79	– 98/79	Website EUDAMED record Report an error
ImmuChrom	Germany	HPLC testkit Homocysteine98/79	– 98/79	info@immuchrom.de EUDAMED record Report an error
Jiangsu Confidence Medical Technology EU representative : JOYSUN GROUP S.L.U (Spain)	China	D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)6 refs98/79	– 98/79	EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Test Kit (Fluorescence Immunoassay)98/79	– 98/79	marketing@hongweitest.com EUDAMED record Report an error
Jiezibio EU representative : SUNGO Europe B.V. (Netherlands)	China	10tests/kit98/79	– 98/79	EUDAMED record Report an error
Konsung EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Test Kit (Immunofluorescence Method)98/79	– 98/79	info@konsung.com EUDAMED record Report an error
Medicon Hellas	Greece	D-DIMER3 refs	C IVDR	Website EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)2 refs	C IVDR	EUDAMED record Report an error
Moelab	Germany	möLab® D-Dimer Test98/79	– 98/79	Website info@moelab.de EUDAMED record Report an error
Mpbio	Germany	Diagnostic Kit for D-Dimer 07CTNL502598/79	– 98/79	Website EUDAMED record Report an error
NanoEntek EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	FREND D-Dimer98/79	– 98/79	Website eudamed@nanoentek.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Rochester EU representative : Ortho-Clinical Diagnostics France (France)	United States	VITROS Chemistry Products HCY 2 Reagent98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
PHC EU representative : PHC Europe B.V. (Netherlands)	Japan	PATHFAST D-Dimer	C IVDR	EUDAMED record Report an error
Poclight EU representative : HUMISS TRADING S. L. (Spain)	China	D-dimer TestKit (Homogeneous Chemiluminescence Immunoassay)98/79	– 98/79	info@poclight.com EUDAMED record Report an error
Probe & go Labordiagnostica	Germany	Glucose Lösung	A IVDR	Website info@probe-go.de EUDAMED record Report an error
Quidel Cardiovascular EU representative : MDSS GmbH (Germany)	United States	Triage D-Dimer2 refs98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	D-Dimer Rapid Test Device – WB/P98/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands)	China	D-Dimer Test Kit (Fluorescence Immunochromatographic Assay)98/79	– 98/79	Website service@reetoo.com.cn EUDAMED record Report an error
ReLIA Biotechnologies (Jiangsu) EU representative : Luxus Lebenswelt GmbH (Germany)	China	ReLIA6 refs98/79	– 98/79	EUDAMED record Report an error
Roche	Germany	CoaguChek XS PT Test PST9 refs	C IVDR	Website EUDAMED record Report an error
Shenzhen Channel Biotechnology EU representative : Luxus Lebenswelt GmbH (Germany)	China	D-Dimer (D-D) Determination Kit (Chemiluminescence Immunoassay) 10 Tests/Kit or 20 Tests/Kit98/79	– 98/79	Website service.channel@szchenna.com EUDAMED record Report an error
Shenzhen Kang Sheng Bao Bio-Technology EU representative : QbD RepS BV (Belgium)	China	D-Dimer Rapid Detect98/79	– 98/79	Website info@ksbbiotech.com EUDAMED record Report an error
Sichuan Xincheng Biological EU representative : CMC Medical Devices & Drugs SL (Spain)	China	25 Tests98/79	– 98/79	EUDAMED record Report an error
Sunbiote EU representative : Lotus NL B.V. (Netherlands)	China	Imidazole Buffer Solution2 refs	A IVDR	Website EUDAMED record Report an error
Suzhou Hokapi Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	HOKAPI™ D-DIMER3 refs	C IVDR	EUDAMED record Report an error
Suzhou Sym-Bio Lifescience EU representative : Emergo Europe B.V. (Netherlands)	China	50 tests	C IVDR	quality.taicang@revvity.com EUDAMED record Report an error
Tongzhoubio EU representative : VidaQuick Biotech S.L. (Spain)	China	D-Dimer Test Kit YI029-400298/79	– 98/79	EUDAMED record Report an error
Urit EU representative : Medunion S.L. (Spain)	China	D-Dimer Assay Kit (Chemiluminescent Microparticle Immunoassay)98/79	– 98/79	Website service@uritest.com EUDAMED record Report an error
Wesailbio EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Test Kit (Immunofluorescence) 20 tests/kit98/79	– 98/79	EUDAMED record Report an error
Xprecia Testing Pty EU representative : MediMark Europe Sarl. (France)	Australia	Xprecia Stride PT/INR Test Strips98/79	– 98/79	Website EUDAMED record Report an error
Zafena	Sweden	Simple Simon PT98/79	– 98/79	Website info@zafena.se EUDAMED record Report an error
Vitro Scient EU representative : MDSS GmbH (Germany) No model still on the market	Egypt	D-Dimer Turbilatex 50 Tests - 7050198/79 (no longer marketed) FDP 15 Tests - 3050198/79 (no longer marketed) Fibrinogen 20 Tests - 3040198/79 (no longer marketed) Partial Thromboplastin Time 1 X 4 ml - 3030198/79 (no longer marketed) Partial Thromboplastin Time 10 X 4 ml - 3030698/79 (no longer marketed) 18 others Partial Thromboplastin Time 4 X 5 ml - 3030498/79 (no longer marketed) Partial Thromboplastin Time 5 X 3 ml - 3030398/79 (no longer marketed) Partial Thromboplastin Time 5 X 4 ml - 3030598/79 (no longer marketed) Partial Thromboplastin Time 8 X 2 ml - 3030298/79 (no longer marketed) Plasma Control L-1 1 ml - 3060198/79 (no longer marketed) Plasma Control L-2 3070198/79 (no longer marketed) Prothrombin time (ISI 1.00) 1 X 8 ml - 3020298/79 (no longer marketed) Prothrombin time (ISI 1.00) 10 X 8 ml - 3020598/79 (no longer marketed) Prothrombin time (ISI 1.00) 2 X 8 ml - 3020398/79 (no longer marketed) Prothrombin time (ISI 1.00) 4 X 5 ml - 3020698/79 (no longer marketed) Prothrombin time (ISI 1.00) 6 X 8 ml - 3020498/79 (no longer marketed) Prothrombin time (ISI 1.00) 8 X 2 ml - 3020198/79 (no longer marketed) Prothrombin time (ISI 1.5) 1 X 8 ml - 3010298/79 (no longer marketed) Prothrombin time (ISI 1.5) 10 X 8 ml - 3010598/79 (no longer marketed) Prothrombin time (ISI 1.5) 2 X 8 ml - 3010398/79 (no longer marketed) Prothrombin time (ISI 1.5) 4 X 5 ml - 3010698/79 (no longer marketed) Prothrombin time (ISI 1.5) 6 X 8 ml - 3010498/79 (no longer marketed) Prothrombin time (ISI 1.5) 8 X 2 ml - 3010198/79 (no longer marketed)	– 98/79	Website info@vitroscient.com EUDAMED record Report an error
Chemclin EU representative : MedNet EC-REP GmbH (Germany) No model still on the market	China	LiCA D-Dimer 2 × 100 Tests98/79 (no longer marketed) LiCA D-Dimer 2 × 50 Tests98/79 (no longer marketed) LiCA D-Dimer 4 × 100 Tests98/79 (no longer marketed) LiCA D-Dimer 4 × 50 Tests98/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	Egypt	D-dimer Ddm-Cal-05098/79 (no longer marketed) Fibrinogen Fib-M-050198/79 (no longer marketed) PTT98/79 (no longer marketed)	– 98/79	Website info@nsbiotec.com EUDAMED record Report an error
Biosynex No model still on the market	France	Ksmart D-DIMER98/79 (no longer marketed) Ksmart D-DIMER + Controls98/79 (no longer marketed)	– 98/79	Website reglementaire@biosynex.com EUDAMED record Report an error
Biotime EU representative : Lotus NL B.V. (Netherlands) and 1 other No model still on the market	China	BIOTIME5 refs98/79 (no longer marketed) D-Dimer Rapid Quantitative Test BT210598/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Lionex No model still on the market	Germany	LIODetect® D-Dimer Rapid Test98/79 (no longer marketed)	– 98/79	Website info@lionex.de EUDAMED record Report an error
Rossix No model still on the market	Sweden	Rox Factor IX98/79 (no longer marketed)	– 98/79	Website info@rossix.com EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	D-dimer Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Didn't find it?

Related categories