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Omega 600

by HEINE Optotechnik GmbH & Co. KG

Ref 234275Model OMEGA

Omega 600 (234275) is a Class I device made by Heine Optotechnik GmbH & Co. KG, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 4053755_IO_02_64), 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 Number4053755_IO_02_64 Basic UDI-DI 04053755214785UDI-DIDate22 Oct 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  • Withdrawn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
OMEGA, 234275
Primary DI / UDI-DI
04053755214785
Basic UDI-DI
4053755_IO_02_64
Direct marketing DI
04053755214785
EMDN code
Z12120114 Ophthalmoscopes
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006269

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Properties

Other properties (14, all answered No)