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Shark 8676343

by Richard Wolf GmbH

Ref 8676343Model 10000201447

Shark 8676343 is a pin-indexed adaptor (EU MDR Class I; FDA Class II; FDA product code FJL, Resectoscope) made by Richard Wolf GmbH, registered in EUDAMED on 8 Nov 2025 (Basic UDI-DI 405520711032019-0028403AE) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04055207019719), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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/MDR EUDAMED Number405520711032019-0028403AE Basic UDI-DI 04055207019719UDI-DIDate8 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207019719 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 405520711032019-0028403AE registered 8 Nov 2025 Active
  • FDA GUDID UDI-DI 04055207019719 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207019719
  2. Registered EUDAMED 405520711032019-0028403AE

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Shark
Generic name
Pin-indexed adaptor, reusable
Device name
Adapters
Model / Ref / Catalog
8676343, 10000201447
Description
CONNECTING PART RESECTOSCOPE 26FR color code black, non-rotatable, intermittent flushing, compatible with Shark sheath 8676426, reusable
Primary DI / UDI-DI
04055207019719
Basic UDI-DI
405520711032019-0028403AE
Direct marketing DI
04055207019719
FDA product code
FJL
EMDN code
L060413 Endoscopic urology adapters and connectors, reusable
GMDN term
Pin-indexed adaptor, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Pin-indexed adaptor, 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
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)