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BraceID - COOL ROM Knee orthosis-Regular
EUDAMEDClass I (EU MDR)
Ref 12-0023-1Model 11-0021-40
by Orthobroker
Identity
- Trade Name
- BraceID - COOL ROM Knee orthosis-Regular EUDAMED
- Device Name
- BraceID- 0° Knee Immobiliser-40 EUDAMED
- Model / Reference
- 11-0021-40 EUDAMED12-0023-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404020402052 EUDAMED
- Basic UDI-DI
- 5404020402kneehipFJ EUDAMED
- EMDN Code
- Y061209 KNEE 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 - COOL ROM Knee orthosis-Regular 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 | 5404020402kneehipFJ | Class I | Active |
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Manufacturer
- Manufacturer
- Orthobroker
- EUDAMED SRN
- BE-MF-000000331
Sources (1)
- EUDAMED 1883f42e-5a77-4e62-bb00-a96947efe8be 61 fields · synced Jul 14, 2026