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Spex

by Spex Ltd 1,000+ variants

Part of a family of 32 devices: see the family page

Ref 1300-CUST-007

Spex (1300-CUST-007) is a Class I device made by Spex Ltd, registered in EUDAMED on 11 May 2026 (Basic UDI-DI 94200517ARMU9), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number94200517ARMU9 Basic UDI-DI 09420082911185UDI-DIDate11 May 2026RegisteredStatusActive

Official records

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  • Withdrawn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
Arm Support
Model / reference
1300-CUST-007
Primary DI / UDI-DI
09420082911185
Basic UDI-DI
94200517ARMU9
EMDN code
Y122406 Belts, seats and armrests for wheelchairs
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

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

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Properties

Other properties (14, all answered No)