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Rolyan Sof-Stretch Extension Splint, Black, X-Large, 5/PK
EUDAMEDClass I (EU MDR)
Ref 081081561Model Splinting
Identity
- Trade Name
- Rolyan Sof-Stretch Extension Splint, Black, X-Large, 5/PK EUDAMED
- Device Name
- Splinting EUDAMED
- Model / Reference
- Splinting EUDAMED081081561 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10885914041939 EUDAMED
- Basic UDI-DI
- 08859140000000000000003KQ EUDAMED
- EMDN Code
- M03050202 SYNTHETIC 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
Category: Cotton wool roll, sterile
Rolyan Sof-Stretch Extension Splint, Black, X-Large, 5/PK by Performance Health Supply, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 285cdb43-0bcc-40b6-bdb6-7a70be9e6f2a 61 fields · synced Jul 14, 2026