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8654997

by Richard Wolf GmbH

Ref 8654997Model 10000201484

8654997 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-04055207057315) and listed in FDA GUDID since 29 Mar 2024 (UDI-DI 04055207057315), 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-04055207057315 Basic UDI-DI 04055207057315UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207057315 UDI-DI Date29 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207057315 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207057315 listed 29 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207057315
  2. Registered EUDAMED B-04055207057315

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  • Withdrawn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
Guide tubes for laser therapy
Model / Ref / Catalog
8654997, 10000201484
Description
GUIDE SHEATH LASER THERAPY 600µM 24FR with lateral guide, distal end with ring, reusable
Primary DI / UDI-DI
04055207057315
Basic UDI-DI
B-04055207057315
FDA product code
FDC
EMDN code
U090299 Urogenital endoscopic resection instruments - other
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
Size
Outer Diameter — 8 Millimeter

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

Similar devices in this category

Other devices filed under UROGENITAL ENDOSCOPIC RESECTION INSTRUMENTS - OTHER.

Other devices from Richard Wolf GmbH

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Properties

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