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Rolyan Splint Liner, Beige, Wrist/Hand/Thumb 10pk
EUDAMEDClass I (EU MDR)
Ref 081187004Model Splinting
Identity
- Trade Name
- Rolyan Splint Liner, Beige, Wrist/Hand/Thumb 10pk EUDAMED
- Device Name
- Splinting EUDAMED
- Model / Reference
- Splinting EUDAMED081187004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914018514 EUDAMED
- Basic UDI-DI
- 08859140000000000000003KQ EUDAMED
- EMDN Code
- M03050201 NATURAL CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Rolyan Splint Liner, Beige, Wrist/Hand/Thumb 10pk by Performance Health Supply, LLC — 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 | 08859140000000000000003KQ | Class I | Active |
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Manufacturer
- Manufacturer
- Performance Health Supply, LLC
- EUDAMED SRN
- US-MF-000003318
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 766b7c8e-2ddc-4493-a975-2f973ce130a8 61 fields · synced Jul 9, 2026