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Haematology / haemostasis / immunohaematology / histology / cytologyHaemostasis reagents (coagulation)Haemostasis rapid tests - RT & POC

D-dimer - RT & POC

EMDN code W0103020803

40 manufacturers, 70 models including 64 on the market, 9 countries

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Manufacturers registered in Europe (EUDAMED) 40
  • 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.
ManufacturerCountryRegistered modelsClassContact
Bgi Denmark – 98/79 Website EUDAMED record Report an error
nal von minden Germany – 98/79 Website info@nal-vonminden.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China C IVDR, 98/79 Website contact@diareagent.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 info@alltests.com.cn EUDAMED record Report an error
Vitrosens Türkiye C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Xenta Biomedical Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany) China – 98/79 sales@accubiotech.com EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Aehealth EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 sales@aehealth.com.cn EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain) and 1 other China – 98/79 ra.rep@aichek.com EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 Website EUDAMED record Report an error
Clongene FDA EU representative : HUMISS TRADING S. L. (Spain) and 1 other China – 98/79 Website marketing@clongene.com EUDAMED record Report an error
Eurolyser Austria – 98/79 Website EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 info@genesignbio.com EUDAMED record Report an error
Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website service@genrui-bio.com EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@vivachek.com EUDAMED record Report an error
Widufit Germany – 98/79 Website info@widufit.de EUDAMED record Report an error
Wwhsbio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website info@wwhsbio.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : CEpartner4U (Netherlands) China – 98/79 EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) – 98/79 EUDAMED record Report an error
Biohermes FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Dyonmed Greece – 98/79 Website customerservice@dyonmedical.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 info@biotests.com.cn EUDAMED record Report an error
Hebei Sanxin Pharmaceutical Technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Konsung FDA EU representative : Lotus NL B.V. (Netherlands) China – 98/79 info@konsung.com EUDAMED record Report an error
Lansionbio EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Micropointbio EU representative : Obelis s.a. (Belgium) China – 98/79 Website EUDAMED record Report an error
Mpbio FDA Germany – 98/79 Website EUDAMED record Report an error
Quidel Cardiovascular FDA EU representative : MDSS GmbH (Germany) United States – 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Shenzhen Kang Sheng Bao Bio-Technology EU representative : QbD RepS BV (Belgium) China – 98/79 Website info@ksbbiotech.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 Website sales@szzijian.com EUDAMED record Report an error
Sichuan Xincheng Biological EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Biosynex No model still on the market France – 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
Lionex No model still on the market Germany – 98/79 Website info@lionex.de EUDAMED record Report an error
Sinocare FDA EU representative : Lotus NL B.V. (Netherlands) No model still on the market China – 98/79 RA@sinocare.com EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market China – 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.

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