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Oculan

by Berchtold GmbH & Co. KG 4 variants

Ref COMM0001Model 08858251028124U5

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08858251028124U5 Basic UDI-DI 07613327665123UDI-DIDate21 Jul 2026RegisteredStatusActive

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  • Withdrawn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
COM_TF10468_Oculan
Model / Reference
08858251028124U5, COMM0001
Primary DI / UDI-DI
07613327665123
Basic UDI-DI
08858251028124U5
Direct Marketing DI
07613327665123
EMDN Code
Z12010702 Mobile scialytic lamps
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
DE-MF-000005446

Other devices from Berchtold GmbH & Co. KG

Properties

Other properties (13)

  • Sterile: 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