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Tbs Osteo
EUDAMEDClass IIa (EU MDR)
Ref OS-TBSiModel Software for analysis of bone microarchitecture
Identity
- Trade Name
- TBS OSTEO EUDAMED
- Device Name
- TBS iNsight EUDAMED
- Model / Reference
- Software for analysis of bone microarchitecture EUDAMEDOS-TBSi EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B214OSTBSIV310 EUDAMED+B214OSTBSIV400 EUDAMED
- Basic UDI-DI
- ++B214OSTBSI29 EUDAMED
- Direct Marketing DI
- +B214OSTBSIV310 EUDAMED+B214OSTBSIV400 EUDAMED
- EMDN Code
- Z11900192 BONE DENSITOMETRY SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMEDIreland 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 IIa — 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 | ++B214OSTBSI29 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medimaps Group SA
- EUDAMED SRN
- CH-MF-000039146
- Authorised Representative
- Med-Imaps SASU FR-AR-000038706
Sources (2)
- EUDAMED d35207a2-f55a-4e52-99d8-19f593d104b2 61 fields · synced Jul 11, 2026
- EUDAMED 8189136b-fbbb-468c-ab35-057c62e17841 61 fields · synced May 19, 2026