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8974121

by Richard Wolf GmbH

Ref 8974.121Model 10000201287

8974121 (8974.121) is a device classified as Class IIa in the EU and Class II in the US made by Richard Wolf GmbH, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-04055207023549) and listed in FDA GUDID since 27 Sep 2016 (UDI-DI 04055207023549), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04055207023549 Basic UDI-DI 04055207023549UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207023549 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207023549 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207023549 listed 27 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207023549
  2. Registered EUDAMED B-04055207023549

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  • Withdrawn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

Generic name
Endoscope sheath, reusable
Device name
Gynecological sheaths
Model / Ref / Catalog
10000201287, 8974.121, 8974121
Description
SHEATH FOR HYSTEROSCOPE 12FR WL 246mm, oval, working channel 3Fr, distal end beveled, and telescopes Ø 2.7mm, 30°, with Luer connection, bayonet-cap, reusable
Primary DI / UDI-DI
04055207023549
Basic UDI-DI
B-04055207023549
FDA product code
HIH
EMDN code
U0999 Urogenital endoscopic devices - other
GMDN term
Endoscope sheath, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.1690
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
Size
Outer Diameter — 4 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201287
8974.121
GUDID
8974121
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

Similar devices in this category

Other devices filed under UROGENITAL ENDOSCOPIC DEVICES.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

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