Skip to content

Olympus WA63815A

by Olympus Winter & Ibe GmbH

Ref WA63815A

Olympus WA63815A 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 6 Nov 2026 (Basic UDI-DI B-04042761062589) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 04042761062589), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761062589 Basic UDI-DI 04042761062589UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761062589 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04042761062589 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 04042761062589 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04042761062589
  2. Registered EUDAMED B-04042761062589

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  • Withdrawn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
Grasping forceps, toothed, 3.25 x 400 mm EUDAMED
Olympus GUDID
Generic name
Rigid endoscopic tissue manipulation forceps, reusable
Model / Ref / Catalog
WA63815A
Primary DI / UDI-DI
04042761062589
Basic UDI-DI
B-04042761062589
FDA product code
FGA
EMDN code
L060403 Endoscopic urology forceps, reusable
GMDN term
Rigid endoscopic tissue manipulation forceps, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
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 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: Rigid endoscopic tissue manipulation forceps, reusable

Similar devices in this category

Other devices filed under ENDOSCOPIC UROLOGY FORCEPS, REUSABLE.

Other devices from Olympus Winter & Ibe GmbH

  • Oes Elite WA2C2ASB

    Class II

  • Oes Elite WA2C21LO

    Class II

  • Oes Elite WA2C17BS

    Class II

  • Oes Elite WA2C21BS

    Class II

See all devices from Olympus Winter & Ibe GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)