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Pro11 Miniluxe Premium Pro Prescription Level Foot Orthotic Insoles
EUDAMEDClass I (EU MDR)
Ref B09L8MDF4Q
Identity
- Device Name
- Pro11 Miniluxe Premium Pro Prescription Level Foot Orthotic Insoles EUDAMED
- Model / Reference
- B09L8MDF4Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060614884163 EUDAMED
- Basic UDI-DI
- 506094334P11MLPP1AW 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Pro11 Miniluxe Premium Pro Prescription Level Foot Orthotic Insoles by Pro 11 Wellbeing Limited — Class I — MDR — listed in EUDAMED
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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 | 506094334P11MLPP1AW | 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 3d3d970b-5765-4d5b-bab3-c79192d15569 61 fields · synced Sep 17, 2026