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BraceID-ROM Elbow Orthosis - Right
EUDAMEDClass I (EU MDR)
Ref 12-0060-2Model 11-0061-1
by Orthobroker
Identity
- Trade Name
- BraceID-ROM Elbow Orthosis - Right EUDAMED
- Device Name
- BraceID- OrthoSling Single Unit EUDAMED
- Model / Reference
- 11-0061-1 EUDAMED12-0060-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404020402380 EUDAMED
- Basic UDI-DI
- 5404020402shoulderelbowCA EUDAMED
- EMDN Code
- Y060624 SHOULDER-ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
BraceID-ROM Elbow Orthosis - Right by Orthobroker — 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 | 5404020402shoulderelbowCA | Class I | Active |
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Manufacturer
- Manufacturer
- Orthobroker
- EUDAMED SRN
- BE-MF-000000331
Sources (1)
- EUDAMED 5e38fd06-2e46-4a76-997f-968f0ee2082d 61 fields · synced Jun 18, 2026