Skip to content

89344631

by Richard Wolf GmbH

Ref 89344631Model 10000201390

89344631 is a device classified as Class IIa in the EU and Class I in the US made by Richard Wolf GmbH, registered in EUDAMED on 4 Sep 2026 (Basic UDI-DI B-04055207055007) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04055207055007), 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-04055207055007 Basic UDI-DI 04055207055007UDI-DIDate4 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207055007 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207055007 registered 4 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207055007 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207055007
  2. Registered EUDAMED B-04055207055007

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  • Withdrawn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
89344631, 10000201390
Description
3D-ENDOSCOPE 0° Ø 10MM WL 435MM rigid, TL 500mm, rod lens system
Primary DI / UDI-DI
04055207055007
Basic UDI-DI
B-04055207055007
FDA product code
FWG
EMDN code
Z12029009 Laparoscopes
GMDN term
Rigid endoscope telescope
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4160
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
Angle — 0 degree
Outer Diameter — 10 Millimeter
Length — 435 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I 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)