Rolyan Polycushion Padding
by Performance Health Supply, LLC 2 variants
Part of a family of 271 devices: see the family page
Ref 081263565Model Splinting
Rolyan Polycushion Padding (081263565) is a medical device (EU MDR Class I; EMDN category immobilisation systems and devices) made by Performance Health Supply, LLC, registered in EUDAMED on 21 Feb 2025 (Basic UDI-DI 08859140000000000000003KQ), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08859140000000000000003KQ 00885914068670 | Date21 Feb 2025 | StatusActive |
Official records
- EUDAMED public site 08859140000000000000003KQ
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Splinting
- Model / reference
- Splinting, 081263565
- Primary DI / UDI-DI
- 00885914068670
- Basic UDI-DI
- 08859140000000000000003KQ
- EMDN code
- M030599 Immobilisation systems and devices - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000003318
- Authorised representative
- AR Experts B.V. NL-AR-000023989
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