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Olympus WA2T430A

by Olympus Winter & Ibe GmbH

Ref WA2T430A

Olympus WA2T430A 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 10 Sep 2026 (Basic UDI-DI B-04042761077545), cleared under FDA 510(k) K151191 on 24 Nov 2015 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761077545), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151191

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761077545 Basic UDI-DI 04042761077545UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761077545 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151191 Date24 Nov 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761077545 registered 10 Sep 2026 Active
  • FDA 510(k) K151191 decided 24 Nov 2015 Active
  • FDA GUDID UDI-DI 04042761077545 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151191
  2. Listed FDA GUDID 04042761077545
  3. Registered EUDAMED B-04042761077545

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  • Withdrawn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, 30°, HD, autoclavable OES ELITE EUDAMED
Olympus GUDID
Generic name
Rigid endoscope telescope
Model / Ref / Catalog
WA2T430A
Primary DI / UDI-DI
04042761077545
Basic UDI-DI
B-04042761077545
FDA product code
HIH, FGC
EMDN code
Z12020701 Cystoscopes
GMDN term
Rigid endoscope telescope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1690, 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 · 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 endoscope telescope

Cleared under the same submission (K151191)

Similar devices in this category

Other devices filed under CYSTOSCOPES.

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See all devices from Olympus Winter & Ibe GmbH →

Properties

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