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Olympus WA96204A

by Olympus Winter & Ibe GmbH

Ref WA96204A

Olympus WA96204A is a device classified as Class IIa in the EU and Class II in the US made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI B-04042761070065), cleared under FDA 510(k) K944072 on 11 Jan 1995 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761070065), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K944072

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761070065 Basic UDI-DI 04042761070065UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761070065 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK944072 Date11 Jan 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761070065 registered 14 Sep 2026 Active
  • FDA 510(k) K944072 decided 11 Jan 1995 Active
  • FDA GUDID UDI-DI 04042761070065 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K944072
  2. Listed FDA GUDID 04042761070065
  3. Registered EUDAMED B-04042761070065

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Telescope, 4 mm, 45°, connector for light guide on top, autoclavable EUDAMED
Olympus GUDID
Generic name
Rigid optical rhinoscope
Model / Ref / Catalog
WA96204A
Primary DI / UDI-DI
04042761070065
Basic UDI-DI
B-04042761070065
FDA product code
EOB
EMDN code
Z12021008 Rhinoscopes
GMDN term
Rigid optical rhinoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4760
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 · 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: Rigid optical rhinoscope

Cleared under the same submission (K944072)

and 3 more cleared under K944072

Similar devices in this category

Other devices filed under ENT ENDOSCOPY INSTRUMENTS.

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)