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Olympus WAIR530A

by Olympus Winter & Ibe GmbH

Ref WAIR530A

Olympus WAIR530A is a rigid optical laparoscope (EU MDD Class IIa; FDA Class II) made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-04042761086189), cleared under FDA 510(k) K200542 on 17 Jul 2020 and listed in FDA GUDID since 29 Jul 2020 (UDI-DI 04042761086189), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200542

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761086189 Basic UDI-DI 04042761086189UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761086189 UDI-DI Date29 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200542 Date17 Jul 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761086189 registered 2 Nov 2026 Active
  • FDA 510(k) K200542 decided 17 Jul 2020 Active
  • FDA GUDID UDI-DI 04042761086189 listed 29 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200542
  2. Listed FDA GUDID 04042761086189
  3. Registered EUDAMED B-04042761086189

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  • Withdrawn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 IR, 5.4 mm, 30° ULTRA EUDAMED
Olympus GUDID
Generic name
Rigid optical laparoscope
Model / Ref / Catalog
WAIR530A
Primary DI / UDI-DI
04042761086189
Basic UDI-DI
B-04042761086189
FDA product code
GCJ, HET
EMDN code
Z12029009 Laparoscopes
GMDN term
Rigid optical laparoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500, 884.1720
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 laparoscope

Cleared under the same submission (K200542)

and 4 more cleared under K200542

Similar devices in this category

Other devices filed under LAPAROSCOPES.

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See all devices from Olympus Winter & Ibe GmbH →

Properties

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