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Tempel

by OFF CARR Srl

Ref TEMPEL

Tempel is a Class I device made by OFF CARR Srl, registered in EUDAMED on 16 Apr 2026 (Basic UDI-DI 805390484400DH), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805390484400DH Basic UDI-DI 08053904844005UDI-DIDate16 Apr 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  • Withdrawn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

Model / reference
TEMPEL
Primary DI / UDI-DI
08053904844005
Basic UDI-DI
805390484400DH
Direct marketing DI
08053904844005
EMDN code
Y122106 Rear self-propelled wheelchairs
Device class
Class I
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000024334

Similar devices in this category

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Properties

Other properties (14, all answered No)