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Orthotic Sandals With Great Arch Support
EUDAMEDClass I (EU MDR)
Ref B07B54CQS5
Identity
- Device Name
- Orthotic Sandals With Great Arch Support EUDAMED
- Model / Reference
- B07B54CQS5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060943341764 EUDAMED
- Basic UDI-DI
- 506094334P11OSDLRD1BQ EUDAMED
- EMDN Code
- Y061218 HIP-KNEE-ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Orthotic Sandals With Great Arch Support by Pro 11 Wellbeing Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Select options
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 | 506094334P11OSDLRD1BQ | Class I | Active |
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Manufacturer
- Manufacturer
- Pro 11 Wellbeing Limited
- EUDAMED SRN
- UK-MF-000046854
- Authorised Representative
- Global E-commerce Experts Europe BV NL-AR-000038301
Sources (1)
- EUDAMED 4209358c-3652-4a0f-a615-fd5c13ea4e32 61 fields · synced Jun 18, 2026