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Panoview 8968421

by Richard Wolf GmbH

Ref 8968.421Model 10000201402

Panoview 8968421 (8968.421) 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 4 Sep 2026 (Basic UDI-DI B-04055207023464) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04055207023464), 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-04055207023464 Basic UDI-DI 04055207023464UDI-DIDate4 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207023464 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207023464 registered 4 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207023464 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207023464
  2. Registered EUDAMED B-04055207023464

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  • Withdrawn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
Panoview
Generic name
Rigid optical nephroscope
Device name
Rigid nephroscopes with working channel
Model / Ref / Catalog
10000201402, 8968.421, 8968421
Description
NEPHROSCOPE 12° 12FR WL 225MM rigid, with lateral ocular lens, working channel for instruments up to 6Fr, TL 406mm, rod lens system
Primary DI / UDI-DI
04055207023464
Basic UDI-DI
B-04055207023464
FDA product code
FGA
EMDN code
Z12020705 Nephroscopes
GMDN term
Rigid optical nephroscope
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
Length — 225 Millimeter
Outer Diameter — 4 Millimeter
Angle — 12 degree

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201402
8968.421
GUDID
8968421
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 nephroscope

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Other devices filed under GENITOURINARY ENDOSCOPY INSTRUMENTS.

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Properties

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