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Integral dental unit

by Guangdong Kui Luk Medical Technology Co., Ltd. 11 variants

Ref K3Model K2, K3, K4, K5, K6, K6P, K7, K7P, K8, K8P, K9

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697564884KLXXX39 Basic UDI-DI 06975648840025UDI-DIDate27 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
K2, K3, K4, K5, K6, K6P, K7, K7P, K8, K8P, K9
Primary DI / UDI-DI
06975648840025
Basic UDI-DI
697564884KLXXX39
Direct Marketing DI
06975648840025
EMDN Code
Z12110101 Dental treatment units
Device Class
Class IIa
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000030094
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Dental delivery system

Other devices from Guangdong Kui Luk Medical Technology Co., Ltd.

See all devices from Guangdong Kui Luk Medical Technology Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No