Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)Fibrinolysis

D-dimer

EMDN code W0103020503

128 manufacturers, 344 models including 335 on the market, 20 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 128

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
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	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 17 others 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	– 98/79	EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany)	China	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 others 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	regulationdept@dymind.com EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands)	China	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 6 others 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	– 98/79	Website info@medcaptain.com EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	100 Tests/Kit98/79 200 Tests/Kit98/79 50 Tests/Kit2 refs98/79 R1: 3ml x 9, R2: 3ml x398/79 R1: 4ml x 9, R2: 4ml x 398/79 6 others R1: 5ml x 9, R2: 5ml x 398/79 R1:30mL×1 R2:10mL×198/79 R1:30mL×2 R2:10mL×298/79 R1:3mL×6 R2:3mL×298/79 R1:9mL×3 R2:3mL×398/79 R1:9mL×6 R2:3mL×698/79	– 98/79	Website support@rayto.com EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other	China	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 5 others 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 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	C IVDR, 98/79	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 5 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 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
Sanymed	Italy	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 4 others 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	– 98/79	Website info@sanymed.it 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
Maccura EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	D-Dimer EBL210100898/79 D-Dimer EBL210200898/79 D-Dimer EBL210300898/79 D-Dimer EBL210400898/79 D-Dimer EBL210500898/79 2 others D-Dimer EBL210600898/79 D-Dimer EBL210700898/79	– 98/79	Website 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
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany)	Egypt	D-Dimer Turbi Latex98/79 D-Dimer Turbi Latex 585 001-198/79 D-Dimer Turbi Latex 585 00298/79 D-Dimer Turbi Latex 585 002-198/79 D-Dimer Turbi Latex 585 00398/79 1 other D-Dimer Turbi Latex 585 00498/79	– 98/79	Website info@spectrum-diagnostics.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany)	China	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 FI-DDM-40298/79 D-Dimer Test Cassette(WB/P)98/79 1 other D-Dimer Test Kit (CLIA)98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Lifotronic FDA 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 1 other D-dimer Assay Kits (Lateral Flow Immunoassay)3 refs	C IVDR, 98/79	Website 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/kit98/79 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
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium)	Japan	AIA-PACK D-Dimer 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 ST AIA-PACK D-Dimer CALIBRATOR SET98/79 1 other ST AIA-PACK D-Dimer SAMPLE DILUTING SOLUTION98/79	– 98/79	csc@tosoh.co.jp 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 FDA 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 FDA 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
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 D-Dimer Kit98/79 Omlipo D-Dimer Kit98/79	– 98/79	Website export@goldsite.com.cn EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy)	United States	HemosIL AcuStar D-Dimer 0009802000 HemosIL D-Dimer 0020008500 HemosIL D-Dimer 500 0020301000 HemosIL D-Dimer HS 0020007700 HemosIL D-Dimer HS 500 0020500100	C IVDR	Website Regulatory@werfen.com 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	– 98/79	EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Fast Test Kit (Immunofluorescence Assay)2 refs D-Dimer Reagent Kit (Immunoturbidimetric Method)98/79 MAGICL D-Dimer (CLIA)98/79 MAGICL DD (CLIA)98/79	C IVDR, 98/79	EUDAMED record Report an error
Monobind FDA 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
Sclavo	Italy	D DIMER GREEN K3000408BK98/79 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	– 98/79	qa@sclavo.it EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	Germany, United Kingdom (ex Northern Ireland)	IMMULITE 2000 D-Dimer IVDR_67_LLB_DUB-C_C_KIT_D-Dimer 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	A, C IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Stago FDA	France	Asserachrom® D-Di98/79 D-Di Test®98/79 STA® - Liatest® D-Di PLUS sthemO DDi M	C IVDR, 98/79	EUDAMED record Report an error
Atlas Medical FDA	Germany	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	– 98/79	Website info@atlas-medical.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
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
Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	D-Dimer Detection Kit (Nephelometry)98/79 D-Dimer Detection Kit (Nephelometry) 2*25 tests98/79 D-Dimer Detection Kit (Nephelometry) 25 tests98/79	– 98/79	Website service@genrui-bio.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	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
Linear FDA	Spain	Clonatest98/79 Cromatest98/79 Cromatetst98/79	– 98/79	Website info@linear.es EUDAMED record Report an error
Nordic Biomarker	Sweden	D-Dimer Latex LRT3 refs MRX Blue D-dimer MRX Green D-dimer	C IVDR	Website info@nordicbiomarker.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	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
Syscanbio EU representative : Obelis s.a. (Belgium)	China	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	– 98/79	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
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
Zybio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	D-Dimer (D-D) Kit(Latex Enhanced Immunoturbidimetric Method)2 refs98/79 D-Dimer Assay (CLIA)98/79 D-Dimer Reagent Kit (Immunoturbidimetric Method)3 refs	C IVDR, 98/79	PMS@zy-ivd.com EUDAMED record Report an error
Biokit FDA	Spain	D-Dimer 01R10013 refs Quantia D-Dimer3 refs	C IVDR	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
Encode EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Rapid Test 1Test/Kit98/79 D-Dimer Rapid Test 25Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
Fortress Diagnostics	Northern Ireland	D-Dimer Latex Kit COAG115D98/79 D-Dimer Latex Kit COAG115E98/79	– 98/79	Website info@fortressdiagnostics.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	– 98/79	EUDAMED record Report an error
Hightopbio FDA 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	100T98/79 50T98/79	– 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
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	– 98/79	Website 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	– 98/79	Website 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	– 98/79	EUDAMED record Report an error
Medconn FDA 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
MedicalSystem Biotechnology FDA 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	– 98/79	EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	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	C IVDR	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 FDA 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 FDA 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
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	D-Dimer Assay Kit (Chemiluminescent Immunoassay)2 refs98/79 D-Dimer Chemiluminescence Immunoassay Kit6 refs98/79	– 98/79	Website info@sansure.com.cn 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
Shenzhen Superbio Technology FDA EU representative : QbD RepS BV (Belgium)	China	D-Dimer Assay Kit CLIA2 refs98/79 Diagnostic Kit for D-Dimer (DD) (Time-resolved Fluorescence Immunochromatographic Assay)98/79	– 98/79	info@sup-bio.com EUDAMED record Report an error
Spinreact	Spain	D-DIMER98/79 D-DIMER MD170923198/79	– 98/79	Website EUDAMED record Report an error
Steellex EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	R1:52ml R2:52ml98/79 R1:54ml R2:54ml98/79	– 98/79	info@steellex.com EUDAMED record Report an error
Tcoag FDA	Ireland	TriniLIA D-dimer98/79 TriniLIA D-Dimer II98/79	– 98/79	Website EUDAMED record Report an error
TECO Medical Instruments, Production + Trading	Germany	Blue D-Dimer LC98/79 Red D-Dimer D2010-01298/79	– 98/79	Website info@teco-medical.com 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
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Finecare2 refs98/79 SmarLumi4 refs98/79	– 98/79	Website sales@wondfo.com.cn 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
Aichek FDA EU representative : Medunion S.L. (Spain)	China	D-Dimer (CLIA)98/79	– 98/79	ra.rep@aichek.com 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 Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	D-Dimer rapid test cassette (Rare earth nano fluorescence immunochromatography)98/79	– 98/79	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
Biolabo	France	BE DDimer D-DIMER Turbidimetric Immunoassay3 refs	C IVDR	support@biolabo.fr EUDAMED record Report an error
bioMérieux FDA	France	VIDAS® D-Dimer Exclusion II™3 refs	C IVDR	EUDAMED record Report an error
Biosystems FDA	Spain	D-DIMER2 refs98/79	– 98/79	Website EUDAMED record Report an error
Bosonbio FDA EU representative : MedPath GmbH (Germany)	China	D-Dimer 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	– 98/79	EUDAMED record Report an error
C.P.M. Compagnia Per La Medicina	Italy	D-DIMER I02276/398/79	– 98/79	Website 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
Diazyme FDA EU representative : MDSS GmbH (Germany)	United States	Diazyme D-Dimer Assay2 refs98/79	– 98/79	Website EUDAMED record Report an error
Erba	Czechia	Erba DDimer R 6098/79	– 98/79	Website EUDAMED record Report an error
Giesse Diagnostics	Italy	D-Dimero 673798/79	– 98/79	Website info@giessediagnostics.com EUDAMED record Report an error
Guangzhou Decheng Biotechnology FDA 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
HangZhou Biotest Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Rightsign MCDIM-LC4198/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Horiba FDA	France	Yumizen G DDi 2 130003639198/79	– 98/79	EUDAMED record Report an error
Hotgen FDA 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
Human	Germany	HemoStat D-Dimer2 refs98/79	– 98/79	Website 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
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 FDA 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
Kalians EU representative : MDSS GmbH (Germany)	Egypt	D-Dimer Turbi Latex98/79	– 98/79	EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	LYSUN DIM-W21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Medicon Hellas FDA	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
NanoEntek FDA 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
Nihon Kohden FDA EU representative : NIHON KOHDEN EUROPE GmbH (Germany)	Japan	Celltac chemi D-dimer DD-421W	C IVDR	Website information@db.nkc.co.jp EUDAMED record Report an error
PHC FDA 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
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	ReLIA4 refs98/79	– 98/79	EUDAMED record Report an error
Responsebio FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	RAMP D-dimer (C1106)98/79	– 98/79	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 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	C IVDR	EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Hemolumi D-Dimer (Latex)8 refs98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	iFlash-D-dimer2 refs	C IVDR	Website info@szyhlo.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Website sales@szzijian.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	– 98/79	Website info@orienterglobal.com EUDAMED record Report an error
Sinocare FDA EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Reagent Kit 2N00198/79	– 98/79	RA@sinocare.com EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	D-Dimer Turbi Latex7 refs98/79	– 98/79	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
Technoclone	Austria	TECHNOLEIA D-Dimer Latex Kit2 refs98/79	– 98/79	Website regulatory@technoclone.com EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany)	China	D-Dimer（CLIA)8 refs98/79	– 98/79	Website sales@tellgen.com EUDAMED record Report an error
Thermofisher FDA	Finland	D-Dimer	C IVDR	Website EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain)	China	D-Dimer Test Kit YI029-400298/79	– 98/79	EUDAMED record Report an error
Urit FDA 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
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
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
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)	– 98/79	Website info@nsbiotec.com 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)	– 98/79	Website info@vitroscient.com EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	Reagent 1: 5×5mL Reagent 2: 5×5mL98/79 (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.

Other manufacturers known in the United States (FDA) 15

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Biomedica ADI Inc.	–	ACTISCREEN XL-FDP XL-FDP agglutination reagent DIMERTEST Latex assay	registered
QUIDEL CARDIOVASCULAR INC. Present in Europe in other categories	–	Triage	registered
Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories	United States	Acute Care™ D-DIMER CalPak Stratus® CS Acute Care™ DDMR TestPak Stratus® CS Acute Care™ DDMR DilPak	K110303 (2011)
NANO-DITECH CORPORATION	United States	Fluoro-CheckTM D-Dimer Nano-CheckTM D-Dimer	registered
Roche Diagnostics Corp. Present in Europe in other categories	United States	D-Dimer Control I/II D-Dimer Calibrator	K033491 (2004)
Kent Laboratories, Inc.	United States	Antiserum to Human Fibrinogen	registered
Biomedica Diagnostics Inc	Canada	–	registered
Diagnostic Automation /Cortez Diagnostics Inc.	United States	–	registered
Diamond Diagnostics Inc. Present in Europe in other categories	United States	–	registered
High Technology, Inc. Present in Europe in other categories	United States	–	registered
KMC Systems	United States	–	registered
Kamiya Biomedical Co. Present in Europe in other categories	United States	–	K030687 (2003)
QuidelOrtho Corporation	United States	–	registered
SHIMA LABORATORIES CO., LTD.	Japan	–	registered
Siemens Healthcare Diagnostic Products GmbH Present in Europe in other categories	Germany	–	K253985 (2026)

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