Identity
- Model / Reference
- FRAX EUDAMEDN.A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065010474000 EUDAMED
- Basic UDI-DI
- 506501047400FRAXBX EUDAMED
- EMDN Code
- Z12040282 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
N.a by Osteoporosis Research Ltd — 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 | 506501047400FRAXBX | Class I | Active |
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Manufacturer
- Manufacturer
- Osteoporosis Research Ltd
- EUDAMED SRN
- GB-MF-000025251
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 7e869658-efa0-4b02-9575-669b97039cf4 61 fields · synced Jun 18, 2026