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95-3909

by SCHÖLLY FIBEROPTIC GmbH

Ref 95-3909Model NIR Camera Heads

95-3909 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 29 May 2026 (Basic UDI-DI 42504801NIRCAMERAHEADSCY) and listed in FDA GUDID since 11 Jun 2025 (UDI-DI 04250480104200), 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 Number42504801NIRCAMERAHEADSCY Basic UDI-DI 04250480104200UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250480104200 UDI-DI Date11 Jun 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42504801NIRCAMERAHEADSCY registered 29 May 2026 Active
  • FDA GUDID UDI-DI 04250480104200 listed 11 Jun 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250480104200
  2. Registered EUDAMED 42504801NIRCAMERAHEADSCY

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  • Withdrawn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
95-3909, NIR Camera Heads
Primary DI / UDI-DI
04250480104200
Basic UDI-DI
42504801NIRCAMERAHEADSCY
Direct marketing DI
04250480104200
FDA product code
FET, GCJ, OWN
EMDN code
Z12020405 Surgical cameras
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
Sterilisation method
Hydrogen Peroxide
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 SURGICAL CAMERAS.

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See all devices from SCHÖLLY FIBEROPTIC GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)