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Drs Light Claver

by Good Doctors Co., Ltd.

Ref Drs Light ClaverModel CL-DC20

Drs Light Claver is a dental/surgical polymerization lamp (EU MDR Class I; FDA Class II; FDA product code EBZ, Activator, Ultraviolet, For Polymerization) made by Good Doctors Co., Ltd., registered in EUDAMED on 24 Jun 2024 (Basic UDI-DI 88000254DC20EY), cleared under FDA 510(k) K093751 on 24 Feb 2010 and listed in FDA GUDID since 30 Oct 2019 (UDI-DI 08800025400081), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093751

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000254DC20EY Basic UDI-DI 08800025400081UDI-DIDate24 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800025400081 UDI-DI Date30 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093751 Date24 Feb 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000254DC20EY registered 24 Jun 2024 Active
  • FDA 510(k) K093751 decided 24 Feb 2010 Active
  • FDA GUDID UDI-DI 08800025400081 listed 30 Oct 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K093751
  2. Listed FDA GUDID 08800025400081
  3. Registered EUDAMED 88000254DC20EY

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Dental/surgical polymerization lamp
Device name
Curing light
Model / reference
CL-DC20, Drs Light Claver
Primary DI / UDI-DI
08800025400081
Basic UDI-DI
88000254DC20EY
510(k) Number
FDA product code
EBZ
EMDN code
Z129004 Light sources
GMDN term
Dental/surgical polymerization lamp
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.6070
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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.

Manufacturer details

EUDAMED SRN
KR-MF-000035314
Authorised representative
Good Doctors Germany GmbH DE-AR-000025472

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Properties

  • Serial number
Other properties (24, all answered No)