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Olympus A47610A

by Olympus Winter & Ibe GmbH

Ref A47610A

Olympus A47610A 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-04042761024105) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761024105), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761024105 Basic UDI-DI 04042761024105UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761024105 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04042761024105 registered 10 Sep 2026 Active
  • FDA GUDID UDI-DI 04042761024105 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04042761024105
  2. Registered EUDAMED B-04042761024105

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  • Withdrawn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
Sheath, 6.5 mm, continuous flow, 5 Fr. channel EUDAMED
Olympus GUDID
Generic name
Endoscope sheath, reusable
Model / Ref / Catalog
A47610A
Primary DI / UDI-DI
04042761024105
Basic UDI-DI
B-04042761024105
FDA product code
GCP
EMDN code
Z12020704 Hysteroscopes
GMDN term
Endoscope sheath, reusable
Device class
Class IIa 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 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

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Properties

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