| OSANG Healthcare FDA
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
34 others
|
C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Lifescan FDA
EU representative : LifeScan Deutschland GmbH (Germany)
|
Switzerland
|
29 others
|
–
98/79
|
info@lifescan.ch
EUDAMED record
Report an error
|
| Vivachek FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
23 others
|
A
IVDR, 98/79
|
info@vivachek.com
EUDAMED record
Report an error
|
| Taidoc FDA
EU representative : MedNet EC-REP GmbH (Germany)
|
Taiwan
|
22 others
|
–
98/79
|
Website
sales@taidoc.com
EUDAMED record
Report an error
|
| YASEE BioMedical FDA
EU representative : Prolinx GmbH (Germany)
|
China
|
20 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Epsbio FDA
EU representative : Obelis s.a. (Belgium)
|
Taiwan
|
9 others
|
C
IVDR, 98/79
|
Website
info@epsbio.com.tw
EUDAMED record
Report an error
|
| Biohermes FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
8 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Sejoy FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
8 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Cofoe FDA
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
7 others
|
C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Biochemical Systems International
|
Italy
|
6 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Aconbio
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
5 others
|
C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Sinocare FDA
EU representative : SUNGO Europe B.V. (Netherlands) and 1 other
|
China
|
5 others
|
C
IVDR, 98/79
|
RA@sinocare.com
EUDAMED record
Report an error
|
| Tysonbio FDA
EU representative : MDSS GmbH (Germany)
|
Taiwan
|
5 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Ascensia FDA
EU representative : Ascensia Diabetes Care Italy Srl (Italy)
|
Switzerland
|
5 others
|
C
IVDR, 98/79
|
Website
EUDAMED-info@ascensia.com
EUDAMED record
Report an error
|
| 77 Elektronika Műszeripari Kft
|
Hungary
|
4 others
|
C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Bioland FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
3 others
|
C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Jiangxi Aicare Medical Technology FDA
EU representative : Caretechion GmbH (Germany)
|
China
|
2 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| General Life Biotechnology FDA
EU representative : MDSS GmbH (Germany)
|
Taiwan
|
3 others
|
–
98/79
|
Website
service@glbiotech.com.tw
EUDAMED record
Report an error
|
| Foracare FDA
EU representative : MedNet EC-REP GmbH (Germany)
|
Switzerland
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Eaglenos FDA
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Arkray FDA
EU representative : ARKRAY Europe, B.V. (Netherlands)
|
Japan
|
2 others
|
–
98/79
|
support_arkrayeurope@arkray.co.jp
EUDAMED record
Report an error
|
| Hmdbio FDA
EU representative : Luana Med. B.V. (Netherlands)
|
Taiwan
|
|
–
98/79
|
Website
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
|
| GB Lifecare
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
|
C
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
|
| Guilin Royalyze Medical Instrument
EU representative : Caretechion GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Swiscare Technology
EU representative : MedNet EC-REP GmbH (Germany)
|
Taiwan
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Abbott FDA
EU representative : Abbott B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Empecs FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
|
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
|
| Lysunbio FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Scienco Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
Taiwan
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Terumo FDA
EU representative : TERUMO EUROPE N.V. (Belgium)
|
Japan
|
|
–
98/79
|
Eudamed_LAA@terumo.co.jp
EUDAMED record
Report an error
|
| 77 Elektronika Műszeripari Korlátolt Felelősségű Társaság
|
Hungary
|
|
IIa
MDR
|
Website
EUDAMED record
Report an error
|
| Abiores Technology (Beijing)
EU representative : Wellkang Ltd (Northern Ireland)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Careforu
EU representative : Meridius Medical Europe Limited (Ireland)
|
South Korea
|
|
–
98/79
|
Website
sales@careforu.co.kr
EUDAMED record
Report an error
|
| Changsha Contec Yixin Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
C
IVDR
|
EUDAMED record
Report an error
|
| Contecmed FDA
EU representative : Prolinx GmbH (Germany)
|
China
|
|
C
IVDR
|
Website
pms.qms@contecmed.com
EUDAMED record
Report an error
|
| GenBody FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
C
IVDR
|
EUDAMED record
Report an error
|
| i-SENS FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
C
IVDR
|
Website
regulatory@i-sens.com
EUDAMED record
Report an error
|
| Leisonbio
EU representative : MedNet EC-REP GmbH (Germany)
|
Taiwan
|
|
–
98/79
|
Website
service@leisonbio.com
EUDAMED record
Report an error
|
| Novatech Tibbi̇ Ci̇haz Ürünleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
|
Türkiye
|
|
–
98/79
|
Website
info@novadiag.com
EUDAMED record
Report an error
|
| OK biotech FDA
EU representative : MDSS GmbH (Germany)
|
Taiwan
|
|
–
98/79
|
Website
service@okbiotech.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
|
| Roche FDA
|
Germany
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| SD Biosensor FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
–
98/79
|
Website
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
|
| Wholecare Biomedical FDA
EU representative : MDSS GmbH (Germany)
|
Taiwan
|
|
–
98/79
|
info.wholecare@microlife.com.tw
EUDAMED record
Report an error
|
| Beijingyicheng
EU representative : Caretechion GmbH (Germany)
No model still on the market
|
China
|
|
–
98/79
|
Website
mail@beijingyicheng.com.cn
EUDAMED record
Report an error
|