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Pro11 Wellbeing Worx Series Orthotic Insoles
EUDAMEDClass I (EU MDR)
Ref B09MFZTWHX
Identity
- Device Name
- Pro11 Wellbeing Worx Series Orthotic Insoles EUDAMED
- Model / Reference
- B09MFZTWHX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060943341634 EUDAMED
- Basic UDI-DI
- 506094334P11WRX15R EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Pro11 Wellbeing Worx Series Orthotic Insoles by Pro 11 Wellbeing Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: PRO11 WELLBEING CHILDREN'S ORTHOTIC 3/4 INSOLES
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 | 506094334P11WRX15R | 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 39e23bbd-2aae-427a-a5f7-fbc4725d7fdf 61 fields · synced Jun 19, 2026