| Medcaptain FDA
EU representative : R Sight B.V. (Netherlands)
|
China
|
6 others
|
–
98/79
|
Website
info@medcaptain.com
EUDAMED record
Report an error
|
| Dymind
EU representative : Eunitor GmbH (Germany)
|
China
|
5 others
|
–
98/79
|
regulationdept@dymind.com
EUDAMED record
Report an error
|
| Rayto
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
5 others
|
–
98/79
|
Website
support@rayto.com
EUDAMED record
Report an error
|
| Realmindbio
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
1 other
|
–
98/79
|
EUDAMED record
Report an error
|
| Dirui FDA
EU representative : Emergo Europe B.V. (Netherlands)
|
China
|
- Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay)3 refs
- Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 1×10mL, R2: 1×10mL, Diluent: 1×55mL98/79
- Fibrin (Fibrinogen) Degradation Products 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
- Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay) R1: 5×5mL, R2: 5×5mL, Diluent: 1×55mL98/79
- Fibrin (Fibrinogen) Degradation Products 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
|
C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Stago FDA
|
France
|
|
B
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Lifotronic FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other
|
China
|
|
C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Shenzhen Drawray Biotech
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
Website
info@szdrawray.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
|
| Hunan AccuBio Biotech
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
–
98/79
|
info@hn-accubio.com
EUDAMED record
Report an error
|
| Illumaxbio
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Jiangxi Medicalsystem Biological Technology
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Beijing Applied Biological Technologies
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Biokit FDA
|
Spain
|
|
C
IVDR
|
EUDAMED record
Report an error
|
| C-Luminary Biotechnology
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Getein FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Giesse Diagnostics
|
Italy
|
|
–
98/79
|
Website
info@giessediagnostics.com
EUDAMED record
Report an error
|
| Guangzhou KOFA Biotechnology
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Isiabio
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Lansionbio
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Maccura
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| MedicalSystem Biotechnology FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Mindray FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Nanjing Norman Biological Technology
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Nordic Biomarker
|
Sweden
|
|
–
98/79
|
Website
info@nordicbiomarker.com
EUDAMED record
Report an error
|
| Pushkang
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| ReLIA Biotechnologies (Jiangsu)
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Sansure FDA
EU representative : Obelis s.a. (Belgium)
|
China
|
|
–
98/79
|
Website
info@sansure.com.cn
EUDAMED record
Report an error
|
| Shenzhen AmTech Bioengineering
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Shenzhen New Industries Biomedical Engineering FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Shenzhen Superbio Technology FDA
EU representative : QbD RepS BV (Belgium)
|
China
|
|
–
98/79
|
info@sup-bio.com
EUDAMED record
Report an error
|
| Shenzhen Yhlo Biotech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
C
IVDR
|
Website
info@szyhlo.com
EUDAMED record
Report an error
|
| Shenzhen Zijian Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
sales@szzijian.com
EUDAMED record
Report an error
|
| Sichuan Orienter Biotechnology
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
Website
info@orienterglobal.com
EUDAMED record
Report an error
|
| Syscanbio
EU representative : Obelis s.a. (Belgium)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Tellgencorp
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
Website
sales@tellgen.com
EUDAMED record
Report an error
|
| Wondfo FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
sales@wondfo.com.cn
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
|
| Zybio FDA
EU representative : QbD RepS BV (Belgium)
|
China
|
|
C
IVDR
|
PMS@zy-ivd.com
EUDAMED record
Report an error
|
| Wuhan Easydiagnosis Biomedicine
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
No model still on the market
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Vitro Scient
EU representative : MDSS GmbH (Germany)
No model still on the market
|
Egypt
|
|
–
98/79
|
Website
info@vitroscient.com
EUDAMED record
Report an error
|