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Shark 46782603

by Richard Wolf GmbH

Ref 46782603Model 10000201075

Shark 46782603 is a device classified as Class IIb 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-04055207053508) and listed in FDA GUDID since 28 Jun 2017 (UDI-DI 04055207053508), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04055207053508 Basic UDI-DI 04055207053508UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207053508 UDI-DI Date28 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207053508 registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207053508 listed 28 Jun 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207053508
  2. Registered EUDAMED B-04055207053508

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  • Withdrawn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
Shark
Generic name
Endoscopic electrosurgical electrode, monopolar, single-use
Device name
Electrodes for HF surgery generator
Model / Ref / Catalog
46782603, 10000201075
Primary DI / UDI-DI
04055207053508
Basic UDI-DI
B-04055207053508
FDA product code
FAS
EMDN code
U090202 Prostatectomy loops
GMDN term
Endoscopic electrosurgical electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.4300
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 8.66666666666 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Endoscopic electrosurgical electrode, monopolar, single-use

Similar devices in this category

Other devices filed under UROGENITAL ENDOSCOPIC RESECTION INSTRUMENTS.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)