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E-Line 8668225

by Richard Wolf GmbH

Ref 8668.225Model 10000201060

E-Line 8668225 (8668.225) 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-04055207019313) and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 04055207019313), 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-04055207019313 Basic UDI-DI 04055207019313UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207019313 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207019313 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207019313 listed 26 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207019313
  2. Registered EUDAMED B-04055207019313

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  • Withdrawn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
Resectoscope
Device name
Working elements, HF
Model / Ref / Catalog
10000201060, 8668.225, 8668225
Description
WORKING ELEMENT PASSIVE MONO 25° closed, compatible with telescopes Ø 4mm, bayonet-cap, reusable
Primary DI / UDI-DI
04055207019313
Basic UDI-DI
B-04055207019313
FDA product code
FDC
EMDN code
U090299 Urogenital endoscopic resection instruments - other
GMDN term
Resectoscope
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 — 25 degree

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201060
8668.225
GUDID
8668225
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: Resectoscope

Similar devices in this category

Other devices filed under UROGENITAL ENDOSCOPIC RESECTION INSTRUMENTS - OTHER.

Other devices from Richard Wolf GmbH

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Properties

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