Identity
- Trade Name
- TBS Osteo EUDAMED
- Device Name
- TBS Calibration Phantom EUDAMED
- Model / Reference
- V3 EUDAMEDOS-PTM EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+B214OSPTMV30 EUDAMED
- Basic UDI-DI
- ++B214OSPTM55 EUDAMED
- Direct Marketing DI
- *+B214OSPTMV30 EUDAMED
- EMDN Code
- Z11900182 BONE DENSITOMETRY SYSTEMS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TBS Osteo by medimaps group SA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B214OSPTM55 | Class I | Active |
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Manufacturer
- Manufacturer
- Medimaps Group SA
- EUDAMED SRN
- CH-MF-000039146
- Authorised Representative
- Med-Imaps SASU FR-AR-000038706
Sources (1)
- EUDAMED 08af4863-2716-4401-8492-4e3348181dc5 61 fields · synced Jun 17, 2026