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41.0600d

by SCHÖLLY FIBEROPTIC GmbH

Ref 41.0600dModel Sealings for Instrument Ports for Uretero-Renoscopy

41.0600d is a device classified as Class I in the EU and Class II in the US made by SCHÖLLY FIBEROPTIC GmbH, registered in EUDAMED on 2 Jun 2026 (Basic UDI-DI 42504801URSSEALINGS6Y) and listed in FDA GUDID since 12 Sep 2024 (UDI-DI 04250480105603), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42504801URSSEALINGS6Y Basic UDI-DI 04250480105603UDI-DIDate2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250480105603 UDI-DI Date12 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42504801URSSEALINGS6Y registered 2 Jun 2026 Active
  • FDA GUDID UDI-DI 04250480105603 listed 12 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250480105603
  2. Registered EUDAMED 42504801URSSEALINGS6Y

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  • Withdrawn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

Generic name
Endoscope working-channel valve, single-use
Model / reference
41.0600d, Sealings for Instrument Ports for Uretero-Renoscopy
Primary DI / UDI-DI
04250480105603
Basic UDI-DI
42504801URSSEALINGS6Y
FDA product code
FGB
EMDN code
Z12020785 Genitourinary endoscopy instruments - consumables
GMDN term
Endoscope working-channel valve, single-use
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
MRI safety
MR Unsafe

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: Endoscope working-channel valve, single-use

Similar devices in this category

Other devices filed under GENITOURINARY ENDOSCOPY INSTRUMENTS - CONSUMABLES.

Other devices from SCHÖLLY FIBEROPTIC GmbH

  • PE591A

    Class IIa

  • SmartVue®

    Class I

  • 41.0600d

    Class I

  • 11-0441-A

    Class IIa

See all devices from SCHÖLLY FIBEROPTIC GmbH →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)