Identity
- Device Name
- RBfracture EUDAMED
- Model / Reference
- 3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700002173638 EUDAMED
- Basic UDI-DI
- 57000021736RB02BJ EUDAMED
- Direct Marketing DI
- 05700002173638 EUDAMED
- EMDN Code
- Z11030582 RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Radiobotics ApS
- EUDAMED SRN
- DK-MF-000023156
Sources (1)
- EUDAMED 0397dfe2-7134-4713-843f-4bb96d3e2f1a 61 fields · synced Jun 18, 2026