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Aesculap OP923

by Aesculap AG

Ref OP923

Aesculap OP923 is a fibreoptic light cable (EU MDR Class I; FDA Class II; FDA product code FSS, Light, surgical, floor standing) made by Aesculap AG, registered in EUDAMED on 11 Aug 2026 (Basic UDI-DI 40392390000019713A) and listed in FDA GUDID since 30 Apr 2019 (UDI-DI 04046963730109), active as of 12 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000019713A Basic UDI-DI 04046963730109UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04046963730109 UDI-DI Date30 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000019713A registered 11 Aug 2026 Active
  • FDA GUDID UDI-DI 04046963730109 listed 30 Apr 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046963730109
  2. Registered EUDAMED 40392390000019713A

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Aesculap
Generic name
Fibreoptic light cable, reusable
Device name
Light cable
Model / Ref / Catalog
OP923
Primary DI / UDI-DI
04046963730109
Basic UDI-DI
40392390000019713A
FDA product code
FSS
EMDN code
Z12011080 Laser surgery instruments - hardware accessories
GMDN term
Fibreoptic light cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4580
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Fibreoptic light cable

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Aesculap AG

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (21, all answered No)