Fabricant

Dymind

ChineEntités : Shenzhen Dymind Biotechnology Co., Ltd.

Marchés : Allemagne

Autorisations : UE – classe A, B

Mandataire UE : Eunitor GmbH (Allemagne)

regulationdept@dymind.com

45 catégories, 328 modèles dont 328 en vente, 1 pays

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Control plasma for haemostasis	W0103020702	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 31 autres Antithrombin III Control CTRL-AT III：1×1.0mL (low value)98/79 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 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 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 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 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 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	– 98/79	Fiche EUDAMED Signaler une erreur
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	Cleanser CLE-P3 réf. Cleanser CLR 500mL2 réf. Hematology Analyzer Diluent D-80DIL:10L3 réf. Hematology Analyzer Diluent D-80DR(M)3 réf. Hematology Analyzer Diluent DIL-A:20L2 réf. 21 autres Hematology Analyzer Diluent DIL-C:20L2 réf. Hematology Analyzer Diluent DIL-E ,20L Hematology Analyzer Diluent DIL-K:20L3 réf. Hematology Analyzer Diluent DIL-N:10L3 réf. Hematology Analyzer Diluent DIL-R 10L2 réf. Hematology Analyzer Dye D-80FD:12mL3 réf. Hematology Analyzer Dye D-80FR(M)2 réf. Hematology Analyzer Dye FDN-R:24mL3 réf. Hematology Analyzer Lyse D-80LD:500mL，1L，2L，4L；D-80LH:200mL，500mL，1L，2L，4L； D-80LN:500mL，1L，2L，4L；D-80LW:200mL，500mL，1L，2L，4L3 réf. Hematology Analyzer Lyse L1：1L3 réf. Hematology Analyzer Lyse LP3 réf. Hematology Analyzer Lyse LYC-1：1L3 réf. Hematology Analyzer Lyse LYD-1：1L3 réf. Hematology Analyzer Lyse LYE-1：1L Hematology Analyzer Lyse LYG-13 réf. Hematology Analyzer Lyse LYK-13 réf. Hematology Analyzer Lyse LYN-G:1L3 réf. Hematology Analyzer Lyse LYR-1:1L3 réf. Hematology Analyzer Reagent Kit (Diluent and Lyse) PTD-1 25 test/kit2 réf. Hematology Analyzer Reagent Kit PTD-103 25 test/kit2 réf. Sample Diluent PTD-A 25 bottle/bag3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Auto Hematology Analyzer D7-CRP98/79 Auto Hematology Analyzer DF1-CRP3 réf. Auto Hematology Analyzer DF5-CRP98/79 Auto Hematology Analyzer DF502 réf. Auto Hematology Analyzer DF50CRP98/79 20 autres Auto Hematology Analyzer DF5198/79 Auto Hematology Analyzer DF5398/79 Auto Hematology Analyzer DF53CRP98/79 Auto Hematology Analyzer DF5598/79 Auto Hematology Analyzer DH-8098/79 Auto Hematology Analyzer DH-800[T6]CS98/79 Auto Hematology Analyzer DH-800[T7]CS98/79 Auto Hematology Analyzer DH-800[T8]CRP98/79 Auto Hematology Analyzer DH-800[T8]CS98/79 Auto Hematology Analyzer DH-80、DH-82、DH-85、DH-88、DH-88CS2 réf. Auto Hematology Analyzer DH-8298/79 Auto Hematology Analyzer DH-8598/79 Auto Hematology Analyzer DH-870、DH-860、DH-850、DH-820、DH-800[H6]、DH-800[H7]、DH-800[T6]CRP、DH-800[T7]CRP、DH-800[T6]CS、DH-800[T7]CS、DH-870CRP、DH-870CS、DH-860CRP、DH-860CS、DH-850CRP、DH-850CS、DH-820CRP、DH-820CS3 réf. Auto Hematology Analyzer DH712 réf. Auto Hematology Analyzer DH7398/79 Auto Hematology Analyzer DM79X98/79 Auto Hematology Analyzer EH59098/79 Auto Hematology-Immunoassay Glycohemoglobin Analyzer DH-88[H]98/79 Auto Hematology-Immunoassay Glycohemoglobin Analyzer DH-88CS[H] 、 DH-88[H] Portable Multi-Function Analyzer DP-H50 Pro	A, B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Haemostasis controls - other	W0103020799	Coagulation Comprehensive Control CTRL-COM Coag Specification 1：1 × 0.5 mL (low-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 2：1 × 0.5 mL (high-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 3：10 × 0.5 mL (low-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 4：10 × 0.5 mL (high-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 5：1 × 1.0 mL (low-level)98/79 19 autres Coagulation Comprehensive Control CTRL-COM Coag Specification 6：1 × 1.0 mL (high-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 7：10 × 1.0 mL (low-level)98/79 Coagulation Comprehensive Control CTRL-COM Coag Specification 8：10 × 1.0 mL (high-level)98/79 Dymind CAL-PT ,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 mL；Calibrator 6:1×1.0 mL；98/79 Heparin Calibrator CAL Anti-Xa Specification 2：Calibrator 1: 2 ×1.0 mL；Calibrator 2: 2 ×1.0 mL；Calibrator 3: 2 ×1.0 mL98/79 Low Molecular Weight Heparin Control CTRL-LMWH Specification 1 ：1 × 1.0 mL (low-level)98/79 Low Molecular Weight Heparin Control CTRL-LMWH Specification 2 ：1 × 1.0 mL (high-level)98/79 Protein C Calibrator CAL-PC Specification 2：6×0.5 mL/kit (reconstituted volume)98/79 Protein C Calibrator CAL-PC Specification 3：1×1.0 mL/kit (reconstituted volume)98/79 Protein C Calibrator CAL-PC Specification 4：6×1.0 mL/kit (reconstituted volume)98/79 Protein S Calibrator CAL-PS Specification 1 ：1×0.5mL/kit (reconstituted volume)98/79 Protein S Calibrator CAL-PS Specification 2 ：6×0.5mL/kit (reconstituted volume)98/79 Protein S Calibrator CAL-PS Specification 3 ：1×1.0 mL/kit (reconstituted volume)98/79 Protein S Calibrator CAL-PS Specification 4 ：6×1.0mL/kit (reconstituted volume)98/79 Unfractionated Heparin Control CTRL-UFH Specification 2 ：1 × 1.0 mL (high-level)98/79 Von Willebrand Factor Antigen Calibrator CAL-VWF (Ag) Specification 1 ：1 × 0.5 mL/kit98/79 Von Willebrand Factor Antigen Calibrator CAL-VWF (Ag) Specification 2 ：6 × 0.5 mL/kit98/79 Von Willebrand Factor Antigen Calibrator CAL-VWF (Ag) Specification 3 ：1 × 1.0 mL/kit98/79 Von Willebrand Factor Antigen Calibrator CAL-VWF (Ag) Specification 4 ：6 × 1.0 mL/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Haematology controls - other	W0103010599	Hematology Calibrator DM-CAL-5E 3mL×298/79 Hematology Calibrator DM-CAL-5E 3mL×198/79 Hematology Calibrator Model:DM-CAL-5E Specification:3mL×1、3mL×2、3mL×3 Hematology Calibrator Model:DM-CAL-RET ,Specification:3mL×398/79 Hematology Calibrator Model:DM-CAL-RET,Specification：3mL×1、3mL×2、3mL×32 réf. 16 autres Hematology Control DH-RET 3 mL×1 (H)98/79 Hematology Control DH-RET 3 mL×1 (L)98/79 Hematology Control DH-RET 3 mL×1 (N)98/79 Hematology Control DM-6D 3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×198/79 Hematology Control DM-6D 3 mL×2 (N)98/79 Hematology Control DM-6D 3 mL×3 (L)98/79 Hematology Control DM-6D 3 mL×3 (N)98/79 Hematology Control DM-BF 3 mL×2 (L)98/79 Hematology Control DM-BF 3 mL×3 (H)98/79 Hematology Control DM-BF 3 mL×3 (L)98/79 Hematology Control DM-BF 3 mL×3 (N)98/79 Hematology Control DM-RET 3 mL×1 (L)98/79 Hematology Control Model:DM-6D Specification:3 mL(H)×1 、3 mL(H)×2 、3 mL(H)×3 、3 mL (N)×1、3 mL(N)×2 、3 mL(N)×3 、3 mL (L)×1、3 mL(L)×2 、3 mL (L)×3、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×13 réf. Hematology Control Model:DM-BF Specification:3 mL(H)×1、3 mL(H)×2、3 mL(H)×3 、3 mL(N)×1 、3 mL(N)×2 、3 mL(N)×3、、3 mL(L)×1 、3 mL (L)×2、3 mL×3 (L)、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×13 réf. Hematology Control Model:DM-BF Specification:3 mL×1(H)98/79 Hematology Control Model:DM-RET Specification:3 mL(H)×1 、3 mL(H)×2 、3 mL(H)×3 、3 mL×(N)1 、3 mL(N)×2 、3 mL (N)×3、3 mL(L)×1 、3 mL(L)×2 、3 mL(L)×3 、3 mL (H) ×1+3 mL (N) ×1 +3 mL (L) ×13 réf.	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Calibration plasma for haemostasis	W0103020701	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 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 8 autres 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 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 Protein C Calibrator CAL-PC Specification 1：1×0.5 mL/kit (reconstituted volume)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Activated partial thromboplastin time	W0103020102	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 7 autres 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	– 98/79	Fiche EUDAMED Signaler une erreur
Automated 3 part hematology analysers	W0202010201	Auto Bio-Immuno Hematology Analzyer DP-H21 Plus98/79 Auto Hematology Analyzer DH202 réf. Auto Hematology Analyzer DH2198/79 Auto Hematology Analyzer DH2398/79 Auto Hematology Analyzer DH2598/79 7 autres Auto Hematology Analyzer DH2698/79 Auto Hematology Analyzer DH3198/79 Auto Hematology Analyzer DH3398/79 Auto Hematology Analyzer DH36 Auto Hematology Analyzer DH36X98/79 Auto Hematology Analyzer DP-H1098/79 Auto Hematology Analyzer EH36098/79	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
D-dimer	W0103020503	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 6 autres 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	– 98/79	Fiche EUDAMED Signaler une erreur
Fibrinogen assays (factor i)	W0103020201	Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 1 :R1 2.0 mL× 10, R2 5.0 mL×122 réf.98/79 Fibrinogen Assay Kit (Modified Clauss Method) CA-FIB(L) Specification 2 :R1 4.0 mL× 10, R2 30.0 mL× 52 réf.98/79 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 6 autres 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	– 98/79	Fiche EUDAMED Signaler une erreur
Lupus anticoagulant	W0103020606	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 6 autres 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	– 98/79	Fiche EUDAMED Signaler une erreur
Multilevel blood controls	W0103010503	Auto Hematology Analyzer DH-61598/79 Hematology Control Model:DM-6DR , Specification:2mL（H）×298/79 Hematology Control Model:DM-6DR , Specification:2mL（H）×398/79 Hematology Control Model:DM-6DR , Specification:2mL（L）×298/79 Hematology Control Model:DM-6DR , Specification:2mL（L）×398/79 6 autres Hematology Control Model:DM-6DR , Specification:2mL（N）×198/79 Hematology Control Model:DM-6DR , Specification:3mL（H）×198/79 Hematology Control Model:DM-6DR , Specification:3mL（H）×298/79 Hematology Control Model:DM-6DR , Specification:3mL（L）×1+3mL（N）×1+ 3mL（H）×198/79 Hematology Control Model:DM-6DR, Specification:3mL（L）×298/79 Hematology Control Model:DM-6DR,Specification：3mL（L）×1+3mL（N）×1+ 3mL（H）×1、2mL（L）×1+2mL（N）×1+ 2mL（H）×13 réf.	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
Prothrombin time ( quick test )	W0103020101	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 6 autres 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	– 98/79	Fiche EUDAMED Signaler une erreur
Thrombin time / reptilase / batroxobin time	W0103020103	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 6 autres 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	– 98/79	Fiche EUDAMED Signaler une erreur
Antithrombin	W0103020602	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 5 autres 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	– 98/79	Fiche EUDAMED Signaler une erreur
Fibrinogen degradation products	W0103020502	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 5 autres 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	– 98/79	Fiche EUDAMED Signaler une erreur
Haemostasis reagents - other	W01030299	Clotting Tetrachoric Combined Testing Kit (Coagulation Method) CA (PT+APTT) Specification 1: 1 test/kit98/79 Clotting Tetrachoric Combined Testing Kit (Coagulation Method) CA (PT+APTT) Specification 2: 10 tests/kit98/79 Clotting Tetrachoric Combined Testing Kit (Coagulation Method) CA (PT+APTT) Specification 4: 30 tests/kit98/79 Clotting Tetrachoric Combined Testing Kit (Coagulation Method) CA (PT+APTT+ FIB) Specification 2: 10 tests/kit98/79 Clotting Tetrachoric Combined Testing Kit (Coagulation Method) CA (PT+APTT+ FIB) Specification 4: 30 tests/kit98/79 2 autres Clotting Tetrachoric Combined Testing Kit (Coagulation Method) CA (PT+APTT+FIB) Specification 1: 1 test/kit98/79 Clotting Tetrachoric Combined Testing Kit (Coagulation Method) CA (PT+APTT+TT+FIB) Specification 4: 30 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Limited panel cell counting analysers - other	W0202010299	Auto Bio-Immuno Hematology Analzyer DP-H20 Plus98/79 Auto Bio-Immuno Hematology Analzyer DP-H22 Plus98/79 Auto Bio-Immuno Hematology Analzyer DP-H23 Plus98/79 Auto Immuno Hematology Analzyer DP-H2098/79 Auto Immuno Hematology Analzyer DP-H2198/79 2 autres Auto Immuno Hematology Analzyer DP-H2298/79 Auto Immuno Hematology Analzyer DP-H2398/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coagulation factor von willebrand (ag)	W0103020215	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 1 autre 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	Fiche EUDAMED Signaler une erreur
Protein c	W0103020607	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 1 autre 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	– 98/79	Fiche EUDAMED Signaler une erreur
Protein s activity	W0103020608	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 1 autre Protein S Testing Kit (Immunoturbidimetry) CA-PS Specification 6 ：PS buffer: 2×4.0 mL. PS latex reagent: 2×4.0 mL98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Anti xa activity for heparin and doac	W0103020309	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	– 98/79	Fiche EUDAMED Signaler une erreur
Whole blood calibrators	W0103010507	HbA1c Calibrator A1c-CAL 2×1.0 mL（A1c-CAL1, A1c-CAL2）98/79 Hematology Calibrator DM-CAL 3mL × 13 réf. Hematology Calibrator DM-CAL PLUS 3mL × 13 réf. Hematology Calibrator DM-CAL-PF3 réf.	B IVDR, 98/79	Fiche EUDAMED Signaler une erreur
General coagulation tests - other	W0103020199	Clotting Tetrachoric Combined Testing Kit (Coagulation Method) CA (PT+APTT) ：15 tests/kit98/79 Clotting Tetrachoric Combined Testing Kit (Coagulation Method) CA (PT+APTT+FIB)：15 tests/kit98/79 Clotting Tetrachoric Combined Testing Kit (Coagulation Method) CA (PT+APTT+TT+FIB)：15 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Abnormal blood controls	W0103010502	Hematology Control DM-3D High (H):3mL×198/79 Hematology Control DM-5D High (H):3mL×198/79	– 98/79	Fiche EUDAMED Signaler une erreur
Automated coagulometers	W0202020102	Automatic Coagulation Analyzer CA12003 réf. Automatic Coagulation Analyzer CA510、CA520、CA5303 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated whole blood hematology analysers - high routine (throughput > 120 samples/hr)	W0202010103	Auto Hematology Analyzer DH-800[H1]98/79 Auto Hematology Analyzer UN7198/79	– 98/79	Fiche EUDAMED Signaler une erreur
Auxiliary reagents (haemostasis) - other	W0103020999	Cleanser CLG-2：8 mL3 réf. Wash Solution CLG-1：5L3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Coagulometers - consumables	W0202020185	Magnetic bead cuvette 100PCS/Box Optic Cuvette Specification 1: 36PCS/Box2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Normal blood controls	W0103010501	Hematology Control DM-3D High (H):3mL×13 réf. Hematology Control DM-5D High (H):3mL×13 réf.	B IVDR	Fiche EUDAMED Signaler une erreur
Other haemoglobin (types) testing - other	W0103010299	HbA1c Eluent Eluent 13 réf. Hemolytic Agent HA-13 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Rapid test cell count instruments	W02020601	Allergen-Specific IgE Antibody Calibrator Kit (Fluorescence flow cytometry) 25 tests/kit98/79 Auto Immuno Hematology Analyzer DP-H2098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Automated Flow Fluorescence Immunoassay Analyzer MF12803 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated slide stainers	W0202059002	Auto Slide Maker and Stainer SPAT X13 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated systems for the management of pre and post-analysis	W02060101	Automatic Sample Processing System DH-60002 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr)	W0202010102	Auto Hematology Analyzer DH-800[H8]98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Cell counting instruments - other	W02020199	Blood Cell Counting Plate PFD-1B 50 tests/kit	A IVDR	Fiche EUDAMED Signaler une erreur
Complete cell count	W0103010103	Hematology Analysis Reagent Kit PFD-1A 50 tests/kit	A IVDR	Fiche EUDAMED Signaler une erreur
Haemoglobin controls	W0103010504	HbA1c Control Material A1c-QC 2x1.0 mL（A1c-QC1、A1c-QC2）98/79	– 98/79	Fiche EUDAMED Signaler une erreur
High performance liquid chromatography systems - hardware accessories	W0201050280	Chromatography Column（HPLC） 1 stick/box98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Integrated / modular chemistry / immunochemistry instruments - other	W02010399	Auto Bio-immuno Hematology Analyzer DP-H20 Plus98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Reagents for (automated) haematology analyzer - other	W0103010199	Hematology Analyzer Dye D-80FN(M) 6mL2 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Semi-automated coagulometers	W0202020101	Semi-auto Coagulation Analyzer DC1040、DC1041、DC1020、DC10213 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Semi-automated hematology analysers	W0202010202	Semi-auto Chemistry Analyzer DP-C163 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Specific reticulocyte reagents	W0103010102	Hematology Analyzer Lyse LYA-1：1L3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur

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