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Spex

by Spex Ltd 188 variants

Ref 1250-3955-000

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number94200517BACKSUPPORTFL Basic UDI-DI 09420051709928UDI-DIDate3 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09420051709928 UDI-DI Date26 Sep 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Spex EUDAMED
Spex Limited GUDID
Generic Name
Wheelchair back rest
Device Name
Wheelchair Back Support
Model / Reference
1250-3955-000
Primary DI / UDI-DI
09420051709928
Basic UDI-DI
94200517BACKSUPPORTFL
FDA Product Code
KNN
EMDN Code
Y122499 Wheelchairs accessories - other
GMDN Term
Wheelchair back rest
Device Class
Class I
Regulation Number
890.3920
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
NZ-MF-000009327
Authorised representative
BEO MedConsulting Berlin GmbH DE-AR-000006764

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See all devices from Spex Ltd →

Properties

  • Premarket Exempt

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No