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iFIX Arm Rest

by iSYS Medizintechnik GmbH

Ref 55251

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9010279iFIXArmRestGF Basic UDI-DI 09010279001722UDI-DIDate30 Jul 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
55251
Primary DI / UDI-DI
09010279001722
Basic UDI-DI
9010279iFIXArmRestGF
EMDN Code
V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)
Device Class
Class I
Medical Purpose
The iFIX Arm Rest is a non-sterile accessory intended to support the iFIX Product Line on the stabilization of a patient’s arm and hand.

Manufacturer details

EUDAMED SRN
AT-PR-000003101

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Properties

Other properties (1)

  • Sterile: No