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Olympus WA94043A

by Olympus Winter & Ibe GmbH

Ref WA94043A

Olympus WA94043A is a medical device (EU MDD Class IIa; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories; EMDN category argon electrosurgical units (esu)) made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI B-04042761083591) and listed in FDA GUDID since 31 Jul 2020 (UDI-DI 04042761083591), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761083591 Basic UDI-DI 04042761083591UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761083591 UDI-DI Date31 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04042761083591 registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 04042761083591 listed 31 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04042761083591
  2. Registered EUDAMED B-04042761083591

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  • Withdrawn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
Pressure reducer, with connector acc. to CGA No. 580, for Argon Plasma Coagulation EUDAMED
Olympus GUDID
Generic name
Argon-enhanced electrosurgical system gas delivery unit
Model / Ref / Catalog
WA94043A
Primary DI / UDI-DI
04042761083591
Basic UDI-DI
B-04042761083591
FDA product code
GEI
EMDN code
Z12010903 Argon electrosurgical units (esu)
GMDN term
Argon-enhanced electrosurgical system gas delivery unit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Argon-enhanced electrosurgical system gas delivery unit

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Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)