TBS Osteo
Ref OS-PTMModel V3
TBS Osteo (OS-PTM) is a Class I device made by medimaps group SA, registered in EUDAMED on 22 Apr 2024 (Basic UDI-DI ++B214OSPTM55), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++B214OSPTM55 *+B214OSPTMV30 | Date22 Apr 2024 | StatusActive |
Official records
- EUDAMED public site ++B214OSPTM55
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- Withdrawn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/MDR Active
Specification
- Device name
- TBS Calibration Phantom
- Model / reference
- V3, OS-PTM
- Primary DI / UDI-DI
- *+B214OSPTMV30
- Basic UDI-DI
- ++B214OSPTM55
- Direct marketing DI
- *+B214OSPTMV30
- EMDN code
- Z11900182 Bone densitometry systems - software accessories
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CH-MF-000039146
- Authorised representative
- Med-Imaps SASU FR-AR-000038706