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Olympus 00108

by Olympus Winter & Ibe GmbH

Ref O0108

Olympus 00108 is a device classified as Class IIb in the EU and Class II in the US made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-04042761000048) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761000048), active as of 7 Nov 2026.

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

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761000048 Basic UDI-DI 04042761000048UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761000048 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04042761000048 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 04042761000048 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04042761000048
  2. Registered EUDAMED B-04042761000048

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
HF-electrode, button, 5 Fr., flexible EUDAMED
Olympus GUDID
Generic name
Endoscopic electrosurgical electrode, monopolar, reusable
Model / Ref / Catalog
O0108 EUDAMED
00108 GUDID
Primary DI / UDI-DI
04042761000048
Basic UDI-DI
B-04042761000048
FDA product code
GCP
EMDN code
L180602 Endoscopic electrosurgery electrodes, reusable
GMDN term
Endoscopic electrosurgical electrode, monopolar, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
O0108
GUDID
00108
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Endoscopic electrosurgical electrode, monopolar, reusable

Similar devices in this category

Other devices filed under ENDOSCOPIC ELECTROSURGERY ELECTRODES, REUSABLE.

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)