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95-3981

by SCHÖLLY FIBEROPTIC GmbH

Ref 95-3981Model NIR Camera Control Units

95-3981 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 26 Jun 2026 (Basic UDI-DI 42504801NIRCCUSKA) and listed in FDA GUDID since 30 Oct 2023 (UDI-DI 04250480109083), 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 Number42504801NIRCCUSKA Basic UDI-DI Date26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250480109083 UDI-DI Date30 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42504801NIRCCUSKA registered 26 Jun 2026 Active
  • FDA GUDID UDI-DI 04250480109083 listed 30 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250480109083
  2. Registered EUDAMED 42504801NIRCCUSKA

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  • Withdrawn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 video camera
Model / reference
95-3981, NIR Camera Control Units
Primary DI / UDI-DI
04250480109083, 04250480108123
Basic UDI-DI
42504801NIRCCUSKA
Direct marketing DI
04250480108123
04250480109083
FDA product code
FET, GCJ, OWN
EMDN code
Z12020406 Video processors
GMDN term
Endoscope video camera
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
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 video camera

Similar devices in this category

Other devices filed under VIDEO PROCESSORS.

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See all devices from SCHÖLLY FIBEROPTIC GmbH →

Properties

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