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Chromophare CH00000001

by Berchtold Holding GmbH

Ref CH00000001Model 08858250000749SL

Chromophare CH00000001 is a fixed examination/treatment room light (EU MDR Class I; FDA Class I) made by Berchtold Holding GmbH, registered in EUDAMED on 5 Aug 2026 (Basic UDI-DI 08858250000749SL) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07613327296167), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000749SL Basic UDI-DI 07613327296167UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327296167 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000749SL registered 5 Aug 2026 Active
  • FDA GUDID UDI-DI 07613327296167 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327296167
  2. Registered EUDAMED 08858250000749SL

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  • Withdrawn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
Chromophare
Generic name
Fixed examination/treatment room light
Device name
COM_TF10468_Chromophare
Model / Ref / Catalog
CH00000001, 08858250000749SL
Primary DI / UDI-DI
07613327296167
Basic UDI-DI
08858250000749SL
Direct marketing DI
07613327296167
FDA product code
KZF, FSY
EMDN code
Z129004 Light sources
GMDN term
Fixed examination/treatment room light
Device class
Class I
Regulation number
880.6320, 878.4580
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Operating room light systemFixed examination/treatment room light

Similar devices in this category

Other devices filed under LIGHT SOURCES.

Other devices from Berchtold Holding GmbH

See all devices from Berchtold Holding GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)