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Rolyan Splinting Accessories
EUDAMEDClass I (EU MDR)
Ref 81275700Model SplintingRef 81264373Ref 81263508Ref 81281708Ref 81275718Ref 81562925Ref 81275858Ref 81283027Ref 81275874Ref 81264407Ref 81266097Ref 81268630Ref 81264381
Identity
- Trade Name
- ROLYAN SPLINTING ACCESSORIES EUDAMEDROLYAN SPLINTING ACCESSORIES EUDAMED
- Device Name
- Splinting EUDAMED
- Model / Reference
- Splinting EUDAMED81275700 EUDAMED81264373 EUDAMED81263508 EUDAMED81281708 EUDAMED81275718 EUDAMED81562925 EUDAMED81275858 EUDAMED81283027 EUDAMED81275874 EUDAMED81264407 EUDAMED81266097 EUDAMED81268630 EUDAMED81264381 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914030462 EUDAMED00885914026281 EUDAMED00885914025758 EUDAMED00885914032152 EUDAMED00885914030479 EUDAMED00885914069677 EUDAMED00885914068731 EUDAMED00885914032855 EUDAMED00885914068755 EUDAMED00885914026304 EUDAMED00885914027547 EUDAMED00885914028308 EUDAMED00885914026298 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 Splinting Accessories 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 (14)
- EUDAMED ebdd585c-4093-4083-8fda-e49e62f29215 61 fields · synced Aug 3, 2026
- EUDAMED ed13b248-3da3-4485-b0e9-e15752928a02 61 fields · synced May 11, 2026
- EUDAMED 55ddfa3d-b2df-40d2-b2c4-76acd1705667 61 fields · synced May 16, 2026
- EUDAMED 1df5d2b9-8339-461a-b334-c03208e94ffd 61 fields · synced May 16, 2026
- EUDAMED 30e1e3b9-ebe3-44f6-9d10-7f05e9d86176 61 fields · synced May 17, 2026
- EUDAMED 0b18ff11-b775-479c-ba55-47315f8b72f6 61 fields · synced May 17, 2026
- EUDAMED 14b29249-8352-4e82-ac05-65fb5ac5bbc6 61 fields · synced May 17, 2026
- EUDAMED 84c6dcd1-8da1-4713-b6b9-993e6332083e 61 fields · synced May 17, 2026
- EUDAMED a4a1983f-cee6-41c1-a42b-960bdefd3d07 61 fields · synced May 17, 2026
- EUDAMED 30516f2e-efb0-4dd0-bc1d-469c5c00750f 61 fields · synced May 17, 2026
- EUDAMED 65f5c693-7b2b-4a13-9087-afce1869f4f9 61 fields · synced May 17, 2026
- EUDAMED c5e2c3fd-a4bf-4241-a847-a251c111e4ef 61 fields · synced May 18, 2026
- EUDAMED 0dd34404-e8f2-406e-98b4-77e02d9c4437 61 fields · synced May 19, 2026
- EUDAMED 94a3979b-43b4-4e33-9488-83460bef45ce 61 fields · synced Jul 18, 2026