Skip to content

Operation Theatre Light

by Surgical Equipment Co. 8 variants

Ref OCES-108EModel Fixed operation theatre lights

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8908025126OTLIGHTFIXWU Basic UDI-DI 08908025126069UDI-DIDate9 Oct 2024RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Operation Theatre Light
Model / Reference
Fixed operation theatre lights, OCES-108E
Primary DI / UDI-DI
08908025126069
Basic UDI-DI
8908025126OTLIGHTFIXWU
EMDN Code
Z12010701 Fixed scialytic lamps
Device Class
Class I

Manufacturer details

EUDAMED SRN
IN-MF-000043933
Authorised representative
OMC NI MEDICAL LIMITED XI-AR-000019483

Related devices

Category: Operating room light system

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