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8677961

by Richard Wolf GmbH

Ref 8677.961Model 10000201128

8677961 (8677.961) is a device classified as Class I in the EU and Class II in the US made by Richard Wolf GmbH, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-04055207019795) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04055207019795), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04055207019795 Basic UDI-DI 04055207019795UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207019795 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207019795 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207019795 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207019795
  2. Registered EUDAMED B-04055207019795

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  • Withdrawn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
Scalpel, reusable
Device name
Urethrotome scalpels
Model / Ref / Catalog
10000201128, 8677.961, 8677961
Description
SCALPEL 11.5FR CERAMIC SEMICIRCULAR resectoscope for small children, telescope Ø 2.7 mm, cutting position 6 O'clock, for cutting urethral strictures, reusable
Primary DI / UDI-DI
04055207019795
Basic UDI-DI
B-04055207019795
FDA product code
EZO
EMDN code
L06040501 Endoscopic surgery urethrotomes and ureterotomes, reusable
GMDN term
Scalpel, reusable
Device class
Class I 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
Size
Outer Diameter — 3.83333333333 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201128
8677.961
GUDID
8677961
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: Scalpel, reusable

Similar devices in this category

Other devices filed under ENDOSCOPIC UROLOGY INSTRUMENTS, REUSABLE.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

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