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E-Line 8626531

by Richard Wolf GmbH

Ref 8626.531Model 10000201398

E-Line 8626531 (8626.531) 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 7 Sep 2026 (Basic UDI-DI B-04055207018071) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04055207018071), 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-04055207018071 Basic UDI-DI 04055207018071UDI-DIDate7 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207018071 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207018071 registered 7 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207018071 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207018071
  2. Registered EUDAMED B-04055207018071

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  • Withdrawn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

Trade name
E-Line
Generic name
Rigid optical cystourethroscope
Device name
Cystoscopes with working channel
Model / Ref / Catalog
10000201398, 8626.531, 8626531
Description
CYSTOSCOPE 12° 8.0/9.8FR WL 150MM rigid, with lateral ocular lens, working channel 5Fr, atraumatic distal tip, TL 283mm, rod lens system
Primary DI / UDI-DI
04055207018071
Basic UDI-DI
B-04055207018071
FDA product code
FBO
EMDN code
Z12020701 Cystoscopes
GMDN term
Rigid optical cystourethroscope
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
Angle — 12 degree
Length — 150 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201398
8626.531
GUDID
8626531
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 optical cystourethroscope

Similar devices in this category

Other devices filed under CYSTOSCOPES.

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)