← Back to catalogue
Rolyan Sof-Stretch Short Extension Splint, Black, Medium, 1/EA
EUDAMEDClass I (EU MDR)
Ref 081304948Model Splinting
Identity
- Trade Name
- Rolyan Sof-Stretch Short Extension Splint, Black, Medium, 1/EA EUDAMED
- Device Name
- Splinting EUDAMED
- Model / Reference
- Splinting EUDAMED081304948 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914042090 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 Short Extension Splint, Black, Medium, 1/EA by Performance Health Supply, LLC — Class I — MDR — listed in EUDAMED
Similar devices
Also classified as Cotton wool roll, sterile.
- Medical Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
- Delta-Dry® — BSN MEDICAL, INC. · Class I
- JERSEY TUBULAIRE HYDROFUGE 25cm x 25m — MAILL'TUB · Class I
- Tricofix® — BSN MEDICAL, INC. · Class I
- Delta-Lite® Plus — BSN MEDICAL, INC. · Class I
- NOBACAST®-GRÜN 7, 5 CM 3, 6M — NOBAMED Paul Danz AG · Class I
- Dynacast® Prelude — BSN MEDICAL, INC. · Class I
- Dynacast® Prelude Solo — BSN MEDICAL, 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 4caedd8d-8340-409f-af22-b490c03f4c9d 61 fields · synced Aug 4, 2026