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Olympus A3552

by Olympus Winter & Ibe GmbH

Ref A3552

Olympus A3552 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 5 Nov 2026 (Basic UDI-DI B-04042761005258), cleared under FDA 510(k) K904939 on 7 Jan 1992 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761005258), active as of 7 Nov 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K904939

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-04042761005258 Basic UDI-DI 04042761005258UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761005258 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK904939 Date7 Jan 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761005258 registered 5 Nov 2026 Active
  • FDA 510(k) K904939 decided 7 Jan 1992 Active
  • FDA GUDID UDI-DI 04042761005258 listed 21 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-3102-2011 FDA Unclassified (pre-2012) initiated 22 Dec 2010

    The device sterile package seal shows evidence of being breached or was breached

Timeline

4 dated events

  1. Cleared FDA 510(k) K904939
  2. Recall initiated FDA recalls Z-3102-2011
  3. Listed FDA GUDID 04042761005258
  4. Registered EUDAMED B-04042761005258

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  • Withdrawn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
Olympus
Generic name
Endoscope sheath, reusable
Model / Ref / Catalog
A3552
Primary DI / UDI-DI
04042761005258
Basic UDI-DI
B-04042761005258
510(k) Number
FDA product code
EZO
EMDN code
Z12020702 Cystourethroscopes
GMDN term
Endoscope sheath, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.4770
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: Endoscope sheath, reusable

Cleared under the same submission (K904939)

Similar devices in this category

Other devices filed under GENITOURINARY ENDOSCOPY INSTRUMENTS.

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Properties

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