Specimen Collection Kit
by Genfine Biotech(Changzhou) Co., Ltd China EUDAMED
Ref S2:100preps/bag
EMDN W05019099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697489811000007ZG | Date28 Jun 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Specimen Collection Kit
- Model / Reference
- S2:100preps/bag
- Primary DI / UDI-DI
- 06974898111299
- Basic UDI-DI
- 697489811000007ZG
- Direct Marketing DI
- 06974898111299
- EMDN Code
- W05019099 Samples collection devices - other
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000003399
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Genfine Biotech(Changzhou) Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 1c213f0f-bb65-4e81-88aa-e7574812bb25