ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)

Haemostasis rapid tests - RT & POC

EMDN code W01030208

56 manufacturers, 130 models including 121 on the market, 12 countries

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

Manufacturers registered in Europe (EUDAMED) 56

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
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
Aidian FDA	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
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 FDA 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
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
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
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
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
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands)	China	Coagulation Analysis Multi-Calibrator3 refs Coagulation Analysis Multi-Calibrator 10×1mL98/79 Coagulation Analysis Multi-Calibrator 1×1mL98/79	C IVDR, 98/79	EUDAMED record Report an error
Hangzhou Alltest Biotech FDA 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 Test Cassette (Whole Blood/Plasma) FI-DDM-40298/79	– 98/79	info@alltests.com.cn 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
Xenta Biomedical Science FDA 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	– 98/79	Website EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	40 tests/kit2 refs98/79 D-Dimer Test Kit (Immunofluorescence Method) 20 tests/kit98/79 20 tests/kit98/79 (no longer marketed) 5×4 mL98/79 (no longer marketed)	– 98/79	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
Aichek FDA EU representative : Medunion S.L. (Spain) and 1 other	China	D-Dimer Rapid Test D-D-D02a98/79 D-Dimer Test Kit FIA98/79	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Atlas Medical FDA	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	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruHemo5 refs98/79 TruVue98/79	– 98/79	EUDAMED record Report an error
Biohermes FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	BF C063 refs98/79 BF S065 refs98/79	– 98/79	EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	D-Dimer Test (FIA)98/79 Rapid D-Dimer Test Card 1M21C298/79	– 98/79	Website EUDAMED record Report an error
Clongene FDA 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
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
Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands)	China	50T/Kit98/79 D-Dimer test kit (Immunofluorescence) 25T/kit98/79	– 98/79	Website service@genrui-bio.com EUDAMED record Report an error
Milenia Biotec	Germany	Milenia QuickLine HIT Control98/79 STic Expert HIT Control98/79	– 98/79	Website info@milenia-biotec.de EUDAMED record Report an error
Tem Innovations FDA	Germany	ROTROL N 503-2498/79 ROTROL P 503-2598/79	– 98/79	EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Rapid Test VCDI98/79 D-Dimer Test Kit (FIA) VID1198/79	– 98/79	info@vivachek.com 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
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
Sinocare FDA EU representative : Lotus NL B.V. (Netherlands)	China	Prothrombin Time Reagent Kit 1S00198/79 Sinocare98/79 (no longer marketed)	– 98/79	RA@sinocare.com EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : CEpartner4U (Netherlands)	China	R118-11698/79	– 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
Encode EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Filariasis IgG/IgM Rapid Test 25Tests/Kit98/79	– 98/79	Website EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Fast Test Kit (Immunofluorescence Assay)8 refs98/79	– 98/79	EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Rightsign CDIM-C4198/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	D-Dimer Control FDDDI-PN2098/79	– 98/79	quality@healgen.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
Helixgen (GUANGZHOU) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	PT/INR test strip98/79	– 98/79	EUDAMED record Report an error
Konsung FDA 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
Lansionbio EU representative : Lotus NL B.V. (Netherlands)	China	D-Dimer Test Kit (Dry Fluorescence Immunoassay)98/79	– 98/79	EUDAMED record Report an error
Mpbio FDA	Germany	Diagnostic Kit for D-Dimer 07CTNL502598/79	– 98/79	Website EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-Dimer Control FDDDI-PN2098/79	– 98/79	EUDAMED record Report an error
Pushkang EU representative : Sungo Cert GmbH (Germany)	China	1ml*102 refs98/79	– 98/79	EUDAMED record Report an error
Quidel Cardiovascular FDA EU representative : MDSS GmbH (Germany)	United States	Triage D-Dimer2 refs98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Roche FDA	Germany	CoaguChek XS PT Test PST9 refs	C IVDR	Website 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
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	D-dimer Detection Kit(Fluorescence Immunoassay) 25 Tests/kit98/79	– 98/79	Website sales@szzijian.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
TECO Medical Instruments, Production + Trading	Germany	TEClot PT-B98/79	– 98/79	Website info@teco-medical.com EUDAMED record Report an error
Zafena	Sweden	Simple Simon PT98/79	– 98/79	Website info@zafena.se 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
Responsebio FDA EU representative : Emergo Europe B.V. (Netherlands) No model still on the market	Canada	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
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
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

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