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Olympus WA91500A

by Olympus Winter & Ibe GmbH

Ref WA91500A

Olympus WA91500A is a device classified as Class I in the EU and Class II in the US made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 4042761110214L), cleared under FDA 510(k) K133311 on 30 Jul 2014 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761070010), active as of 23 Oct 2026.

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

CE MDR 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) K133311

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/MDR EUDAMED Number4042761110214L Basic UDI-DI 04042761070010UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761070010 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133311 Date30 Jul 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4042761110214L registered 13 May 2026 Active
  • FDA 510(k) K133311 decided 30 Jul 2014 Active
  • FDA GUDID UDI-DI 04042761070010 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K133311
  2. Listed FDA GUDID 04042761070010
  3. Registered EUDAMED 4042761110214L

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Light source, for rigid endoscopes EndoLED EUDAMED
Olympus GUDID
Generic name
Endoscopic light source unit, battery-powered
Device name
Light source (Portable) - EndoLED
Model / Ref / Catalog
WA91500A
Primary DI / UDI-DI
04042761070010
Basic UDI-DI
4042761110214L
Direct marketing DI
04042761070010
510(k) Number
FDA product code
NTN
EMDN code
Z12020402 Light sources for endoscopy and minimally invasive surgery
GMDN term
Endoscopic light source unit, battery-powered
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 light source unit, battery-powered

Cleared under the same submission (K133311)

Similar devices in this category

Other devices filed under LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY.

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  • Oes Elite WA2C21BS

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See all devices from Olympus Winter & Ibe GmbH →

Properties

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