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Rolyan Polycushion Padding

by Performance Health Supply, LLC 2 variants

Part of a family of 271 devices: see the family page

Ref 081419258Model Splinting

Rolyan Polycushion Padding (081419258) 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 European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08859140000000000000003KQ Basic UDI-DI 00885914069295UDI-DIDate21 Feb 2025RegisteredStatusActive

Official records

  • EUDAMED public site Basic UDI-DI 08859140000000000000003KQ — open Devices and search for it

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Splinting
Model / reference
Splinting, 081419258
Primary DI / UDI-DI
00885914069295
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

Similar devices in this category

Other devices filed under IMMOBILISATION SYSTEMS AND DEVICES - OTHER.

Other devices from Performance Health Supply, LLC

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Properties

Other properties (14, all answered No)