Transport Medium
Ref TM001Model TM
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 | Number843604032TM01AP 08436040325551 | Date14 Dec 2022 | 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- Withdrawn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
- Model / Reference
- TM, TM001
- Primary DI / UDI-DI
- 08436040325551
- Basic UDI-DI
- 843604032TM01AP
- EMDN Code
- W0599 IVD general use consumable devices - other
- Device Class
- Class A
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000004099
Other devices from Vircell, S.L
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No