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MEDiBrace Heated Back Support Belt RAY-D8 v2
EUDAMEDClass I (EU MDR)
Ref RAY-D8 v2
Identity
- Device Name
- MEDiBrace Heated Back Support Belt RAY-D8 v2 EUDAMED
- Model / Reference
- RAY-D8 v2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00611188543557 EUDAMED
- Basic UDI-DI
- 611188543557AM EUDAMED
- EMDN Code
- Y061217 THIGH 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
MEDiBrace Heated Back Support Belt RAY-D8 v2 by ProfessorZ Ltd — 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 | 611188543557AM | Class I | Active |
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Manufacturer
- Manufacturer
- ProfessorZ Ltd
- EUDAMED SRN
- UK-MF-000049087
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED be940403-0e19-4224-ac63-e253996d039a 61 fields · synced Jul 21, 2026