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ILO TRIstar 4K

by ILO electronic GmbH

Ref 854-0029Model 3Chip (MOS) UHD camera system

ILO TRIstar 4K (854-0029) is a Class I device made by ILO electronic GmbH, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 42503697854P5) and listed in FDA GUDID since 22 Jun 2023 (UDI-DI 04250369706709), 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 Number42503697854P5 Basic UDI-DI 04250369706709UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250369706709 UDI-DI Date22 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503697854P5 registered 20 May 2026 Active
  • FDA GUDID UDI-DI 04250369706709 listed 22 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250369706709
  2. Registered EUDAMED 42503697854P5

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  • Withdrawn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

Trade name
TRIstar 4K EUDAMED
Ilo GUDID
Generic name
Endoscope video camera
Device name
Endoscopic camera
Model / Ref / Catalog
3Chip (MOS) UHD camera system, 854-0029, TRIstar 4K
Primary DI / UDI-DI
04250369706709
Basic UDI-DI
42503697854P5
Direct marketing DI
04250369706709
FDA product code
KQM
EMDN code
Z12020405 Surgical cameras
GMDN term
Endoscope video camera
Device class
Class I
Regulation number
878.4160
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
3Chip (MOS) UHD camera system
854-0029
GUDID
TRIstar 4K
Sterilise before useEUDAMED
Yes
GUDID
No

Related devices

Category: Endoscope video cameraEndoscopic video image processing unit

Other devices from ILO electronic GmbH

See all devices from ILO electronic GmbH →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)