Identity
- Device Name
- Pro 11 Wellbeing Night Splint Sock EUDAMED
- Model / Reference
- B00SPS6DJ6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060614886464 EUDAMED
- Basic UDI-DI
- 506094334P11NGTSS2Q5 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER 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: Hand/finger splint, reusable
Pro 11 Wellbeing Night Splint Sock by Pro 11 Wellbeing Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: Night Splints
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 | 506094334P11NGTSS2Q5 | 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 d91a3846-11da-4a62-b95d-94d7ae38fa25 61 fields · synced Jul 9, 2026