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Rolyan Splints
EUDAMEDClass I (EU MDR)
Ref 81283126Model SplintingRef 81282565Ref 81280387Ref 81280841Ref 81282607Ref 81280866Ref 81280361Ref 81280858Ref 81280395Ref 81282581
Identity
- Trade Name
- ROLYAN SPLINTS EUDAMED
- Device Name
- Splinting EUDAMED
- Model / Reference
- Splinting EUDAMED81283126 EUDAMED81282565 EUDAMED81280387 EUDAMED81280841 EUDAMED81282607 EUDAMED81280866 EUDAMED81280361 EUDAMED81280858 EUDAMED81280395 EUDAMED81282581 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914032893 EUDAMED00885914032473 EUDAMED00885914031681 EUDAMED00885914031766 EUDAMED00885914032510 EUDAMED00885914031780 EUDAMED00885914031667 EUDAMED00885914031773 EUDAMED00885914031698 EUDAMED00885914032497 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
Yes
EUDAMEDEUDAMED
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 Splints 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 (10)
- EUDAMED 4c185b3e-6182-4fbc-bc25-2aaa289457c2 61 fields · synced Sep 17, 2026
- EUDAMED bbfb0515-4e40-4c46-9758-8725c22c169d 61 fields · synced May 16, 2026
- EUDAMED 7a41b1cf-9ac4-4717-a30b-af2084eecffb 61 fields · synced May 17, 2026
- EUDAMED 49a979b7-7a01-4542-966d-204816a428bd 61 fields · synced May 17, 2026
- EUDAMED 1b2728c5-aad6-4de0-bd43-86d5bf4300da 61 fields · synced May 18, 2026
- EUDAMED 39c7b863-9b48-498a-a76f-af128a857324 61 fields · synced May 18, 2026
- EUDAMED 6f2d3325-64a2-452f-8704-db6ae3159a8c 61 fields · synced May 18, 2026
- EUDAMED 1bdd1e8f-80e4-4ac8-b4d8-26d74fcba2cf 61 fields · synced May 18, 2026
- EUDAMED cd07343e-f0e0-4d27-99a6-f8f2797eb37b 61 fields · synced May 18, 2026
- EUDAMED cda0f0a3-b076-4e4f-9bd3-64da0c55de82 61 fields · synced May 18, 2026