← Back to catalogue
Rolyan Gel Padding, 1/4" (6.4mm)
EUDAMEDClass I (EU MDR)
Ref 081288976Model Splinting
Identity
- Trade Name
- ROLYAN GEL PADDING, 1/4" (6.4MM) EUDAMED
- Device Name
- Splinting EUDAMED
- Model / Reference
- Splinting EUDAMED081288976 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914036266 EUDAMED
- Basic UDI-DI
- 08859140000000000000003KQ EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER 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: Hand/finger splint, reusable
Rolyan Gel Padding, 1/4" (6.4mm) by Performance Health Supply, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand/finger splint, reusable.
- Elastic Bandage — Anji Xinyuan Medical Supplies Co.,Ltd. · Class I
- Plastalume — BROWNMED, INC. · Class I
- Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
- MedTextile — Medtex Swiss Ltd · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Performance Health Supply, LLC
- EUDAMED SRN
- US-MF-000003318
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 4e909b45-34be-43c8-badd-2c267e620be3 61 fields · synced Jul 9, 2026