Watin Biolife
by Watin Biolife Manufacturing Company 99 variants
Ref 2041
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number628704495005BASTG 06287044950056 | Date5 May 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Bhi Agar 5% Sheep Blood
- Model / Reference
- 2041
- Primary DI / UDI-DI
- 06287044950056
- Basic UDI-DI
- 628704495005BASTG
- EMDN Code
- W0104010499 Prepared media in plates - other
- Device Class
- Class A
Manufacturer details
- EUDAMED SRN
- SA-MF-000047358
- Authorised representative
- Advena Limited MT-AR-000000234
Properties
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