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8754401

by Richard Wolf GmbH

Ref 8754.401Model 10000201528

8754401 (8754.401) 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 6 Oct 2026 (Basic UDI-DI B-04055207020432) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04055207020432), 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-04055207020432 Basic UDI-DI 04055207020432UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207020432 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207020432 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207020432 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207020432
  2. Registered EUDAMED B-04055207020432

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  • Withdrawn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 endoscope telescope
Device name
Rigid endoscopes without working channel
Model / Ref / Catalog
10000201528, 8754.401, 8754401
Description
TELESCOPE 0° Ø 2MM WL 268MM rigid, TL 365mm, semi-rigid image carrier
Primary DI / UDI-DI
04055207020432
Basic UDI-DI
B-04055207020432
FDA product code
HIH
EMDN code
Z12029009 Laparoscopes
GMDN term
Rigid endoscope telescope
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 — 2 Millimeter
Length — 268 Millimeter
Angle — 0 degree

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201528
8754.401
GUDID
8754401
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: Rigid endoscope telescope

Similar devices in this category

Other devices filed under LAPAROSCOPES.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

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