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Emdyca

Chemistry / immunochemistry instrumentsChemistry / immunochemistry rapid tests + POC testsVarious rapid test chemistry / immunochemistry instruments ("point of care" and/or emergency)

Various rapid test chemistry / immunochemistry instruments - other

EMDN code W0201069099

72 manufacturers, 241 models including 222 on the market, 16 countries

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Manufacturers registered in Europe (EUDAMED) 72
  • 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
General Life Biotechnology FDA EU representative : MDSS GmbH (Germany) Taiwan
33 others
 C IVDR, 98/79 Website service@glbiotech.com.tw EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
19 others
 A IVDR, 98/79 Website contact@diareagent.com EUDAMED record Report an error
Biohermes FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
13 others
 – 98/79 EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China
10 others
 A IVDR, 98/79 Website EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States
3 others
 A IVDR quality@healgen.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
2 others
 A IVDR EUDAMED record Report an error
Vitrosens Türkiye
1 other
 A IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) China A IVDR, 98/79 info@alltests.com.cn EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR, 98/79 EUDAMED record Report an error
Taidoc FDA EU representative : MedNet EC-REP GmbH (Germany) Taiwan – 98/79 Website sales@taidoc.com EUDAMED record Report an error
Biotime EU representative : Medunion S.L. (Spain) and 1 other China
4 others
 A IVDR EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) United States A IVDR info@acrobiotech.com EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain) China A IVDR Website info@kylinew.com EUDAMED record Report an error
77 Elektronika Műszeripari Kft Hungary A IVDR, 98/79 Website EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain) United States A IVDR info@acesolab.com EUDAMED record Report an error
Bosurebio EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website info@bosurebio.com.cn EUDAMED record Report an error
Guangzhou Decheng Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website service@dochekbio.com EUDAMED record Report an error
Konsung FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Sejoy FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China C IVDR Website EUDAMED record Report an error
Shenzhen Drawray Biotech EU representative : Lotus NL B.V. (Netherlands) China A IVDR Website info@szdrawray.com EUDAMED record Report an error
Abbott FDA Norway A IVDR Website EUDAMED record Report an error
Bgi Denmark A IVDR Website EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Bosonbio FDA EU representative : MedPath GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Coei Biotech EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Denizbiyokimya Türkiye – 98/79 EUDAMED record Report an error
Dxgenco EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR EUDAMED record Report an error
Hangzhou Aokai Biotech EU representative : JOYSUN GROUP S.L.U (Spain) China A IVDR info@aokais.com.cn EUDAMED record Report an error
Institute for Animal Health, Henan Academy of Agricultural Sciences EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
NIOX Sweden B IVDR, 98/79 qa@niox.com EUDAMED record Report an error
P4Q Spain A IVDR sales@p4q.com EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Shenzhen BOSH Diagnostics EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR Website service@boshbio.com EUDAMED record Report an error
Shenzhen Everbest Machinery lndustry EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shenzhen Superbio Technology FDA EU representative : QbD RepS BV (Belgium) China A IVDR info@sup-bio.com EUDAMED record Report an error
Sinocare FDA EU representative : SUNGO Europe B.V. (Netherlands) and 1 other China C IVDR, 98/79 RA@sinocare.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
Biohit FDA Finland A IVDR, 98/79 Website info@biohit.fi EUDAMED record Report an error
A.S.T Italy A IVDR Website info@asteng.it EUDAMED record Report an error
Aichek FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR ra.rep@aichek.com EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States A IVDR Website EUDAMED record Report an error
bioMérieux FDA France A IVDR EUDAMED record Report an error
Biosynex France A IVDR Website reglementaire@biosynex.com EUDAMED record Report an error
Diasia FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website EUDAMED record Report an error
Gc Medis EU representative : Obelis s.a. (Belgium) South Korea – 98/79 Website EUDAMED record Report an error
GENSPEED Biotech Austria A IVDR Website office@genspeed-biotech.com EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
i-SENS FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website regulatory@i-sens.com EUDAMED record Report an error
Infitek FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Kaiwood EU representative : Obelis s.a. (Belgium) Taiwan A IVDR Website service@kaiwood.com.tw EUDAMED record Report an error
Labmaster Finland A IVDR Website EUDAMED record Report an error
Lifotronic FDA EU representative : Umedwings Netherlands B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
MaxBio (Tianjin) Biotechnology EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Meridian Bioscience FDA EU representative : Meridian Bioscience Europe S.r.l. (Italy) United States A IVDR Website EUDAMED record Report an error
Micropointbio EU representative : Obelis s.a. (Belgium) China – 98/79 Website EUDAMED record Report an error
NanoRepro Germany B IVDR Website info@nanorepro.com EUDAMED record Report an error
Poclight EU representative : HUMISS TRADING S. L. (Spain) China A IVDR info@poclight.com EUDAMED record Report an error
Precision Biosensor FDA EU representative : mdi Europa GmbH (Germany) South Korea A IVDR Website info@precision-bio.com EUDAMED record Report an error
ProciseDx FDA EU representative : QbD RepS BV (Belgium) United States A IVDR Website EUDAMED record Report an error
ProtectLife International Biomedical EU representative : MedNet EC-REP GmbH (Germany) Taiwan A IVDR info@protectlife-intl.com EUDAMED record Report an error
Rapid Labs EU representative : VidaQuick Biotech S.L. (Spain) United Kingdom (ex Northern Ireland) A IVDR Website info@rapidlabs.co.uk EUDAMED record Report an error
Rayce Biotechnology (Beijing) EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Realytech EU representative : Medunion S.L. (Spain) China A IVDR Website info@realytech.com EUDAMED record Report an error
Saladax FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR Website regulatory@saladax.com EUDAMED record Report an error
Seamaty EU representative : MedNet EC-REP GmbH (Germany) China A IVDR EUDAMED record Report an error
Seindabio EU representative : Umedwings Netherlands B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR Website info@szyhlo.com EUDAMED record Report an error
Sugentech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR ra@sugentech.com EUDAMED record Report an error
Suzhou Astrabio Technology EU representative : MedPath GmbH (Germany) China A IVDR marketing@astra-biotech.com EUDAMED record Report an error
Tai-Saw Technology EU representative : Emergo Europe B.V. (Netherlands) Taiwan A IVDR Website info@tst.bio EUDAMED record Report an error
Urit FDA EU representative : Medunion S.L. (Spain) China – 98/79 Website service@uritest.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

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

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