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8650604

by Richard Wolf GmbH

Ref 8650.604Model 10000201105

8650604 (8650.604) is a rigid endoscopic biopsy forceps (EU MDD Class I; FDA Class II; FDA product code FBO, Cystourethroscope) made by Richard Wolf GmbH, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI B-04055207018385) and listed in FDA GUDID since 29 Sep 2016 (UDI-DI 04055207018385), 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-04055207018385 Basic UDI-DI 04055207018385UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207018385 UDI-DI Date29 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207018385 registered 3 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207018385 listed 29 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207018385
  2. Registered EUDAMED B-04055207018385

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  • Withdrawn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
Rigid endoscopic biopsy forceps, reusable
Device name
Optical biopsy forceps, non HF
Model / Ref / Catalog
10000201105, 8650.604, 8650604
Description
OPT.BIOPSY FORCEPS SPOON-SHAPED double-action, for biopsies, for sheaths from 19.5Fr, for telescope 0° Ø, for telescope 0° Ø 4mm, with twist lock, reusable
Primary DI / UDI-DI
04055207018385
Basic UDI-DI
B-04055207018385
FDA product code
FBO
EMDN code
L060403 Endoscopic urology forceps, reusable
GMDN term
Rigid endoscopic biopsy 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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201105
8650.604
GUDID
8650604
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 biopsy forceps, reusable

Similar devices in this category

Other devices filed under ENDOSCOPIC UROLOGY FORCEPS, REUSABLE.

Other devices from Richard Wolf GmbH

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Properties

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