Skip to content

Optical Biometer

by Tomey Corporation

Ref OA-2000

Optical Biometer (OA-2000) is a Class IIa device made by Tomey Corporation, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI B-04582273605039), active as of 25 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04582273605039 Basic UDI-DI 04582273605039UDI-DIDate26 Jun 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Optical Biometer
Model / reference
OA-2000
Primary DI / UDI-DI
04582273605039
Basic UDI-DI
B-04582273605039
EMDN code
Z12120102 Computerised optical biometers
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000017923
Authorised representative
Tomey GmbH DE-AR-000011135

Similar devices in this category

Other devices filed under COMPUTERISED OPTICAL BIOMETERS.

Other devices from Tomey Corporation

See all devices from Tomey Corporation →

Properties

  • Measuring function
Other properties (11, all answered No)