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Dental Operating Light DCR-4K

by Medfruition Electronics Technology Co., Ltd

Dental Operating Light DCR-4K is a Class I device made by Medfruition Electronics Technology Co., Ltd, registered in EUDAMED and listed in FDA GUDID since 11 Mar 2024 (UDI-DI 06971951789907), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971951789907 UDI-DI Date11 Mar 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 06971951789907 listed 11 Mar 2024 Listed

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  • Withdrawn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
Dental Operating Light
Generic name
LED dental light, line-powered
Model / reference
DCR-4K
Primary DI / UDI-DI
06971951789907
FDA product code
EAZ
GMDN term
LED dental light, line-powered
Device class
Class I
Regulation number
872.4630
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)