Identity
- Trade Name
- RBfracture EUDAMED
- Device Name
- RBfracture EUDAMED
- Model / Reference
- 2.3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05745001002022 EUDAMED
- Basic UDI-DI
- 57000021736RB02BJ EUDAMED
- Direct Marketing DI
- 05745001002022 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Denmark 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
RBfracture by Radiobotics ApS — 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 | 57000021736RB02BJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Radiobotics ApS
- EUDAMED SRN
- DK-MF-000023156
Sources (1)
- EUDAMED 16c95be5-0023-4afe-b1d7-ac4a291af256 61 fields · synced Jun 18, 2026