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Comfort Shoulder Immobiliser - Large
EUDAMEDClass I (EU MDR)
Ref 11-0065-LModel 11-0061-1
by Orthobroker
Identity
- Trade Name
- Comfort Shoulder Immobiliser - Large EUDAMED
- Device Name
- BraceID- OrthoSling Single Unit EUDAMED
- Model / Reference
- 11-0061-1 EUDAMED11-0065-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404020400898 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
Comfort Shoulder Immobiliser - Large 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 7d549e55-a5a8-4815-9b7c-cf807eefbfff 61 fields · synced Jun 18, 2026