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RBfracture
EUDAMEDClass IIa (EU MDR)
Ref RBfractureRef 2.0Ref RBfracture v.1.8Ref RBfracture 2.5Ref 2.4
Identity
- Trade Name
- RBfracture EUDAMED
- Device Name
- RBfracture EUDAMED
- Model / Reference
- RBfracture EUDAMED2.0 EUDAMEDRBfracture v.1.8 EUDAMEDRBfracture 2.5 EUDAMED2.4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700002173676 EUDAMED05700002173690 EUDAMED05700002173683 EUDAMED05745001002046 EUDAMED05745001002039 EUDAMED
- Basic UDI-DI
- 57000021736RB02BJ EUDAMED
- Direct Marketing DI
- 05700002173676 EUDAMED05700002173690 EUDAMED05700002173683 EUDAMED05745001002046 EUDAMED05745001002039 EUDAMED
- EMDN Code
- Z11030582 RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMEDZ11030592 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 (5)
- EUDAMED 33d553aa-9a5e-451e-9d1d-59abb7bdc1ee 61 fields · synced Aug 3, 2026
- EUDAMED 59adc0c1-87f6-4064-82d6-99b6165c8c34 61 fields · synced May 18, 2026
- EUDAMED cc7032b2-20c2-489e-8043-0ccee0c46313 61 fields · synced May 18, 2026
- EUDAMED acd1e064-5122-4718-a3bc-8283da2e0fde 61 fields · synced May 18, 2026
- EUDAMED 470a8fb1-4783-4301-b3e3-4f8c6de47ab8 61 fields · synced May 19, 2026