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Curing Light Machine

by Foshan Duoyimei Medical Instrument Co., Ltd

Ref SKI-801Model SKI-801,SKI-802,SKI-803,SKI-805,SKI-806,SKI-807,SKI-808

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, self-declared

Class I: no certifier involved

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 Number697881180CLM001KV Basic UDI-DI 06978811800109UDI-DIDate11 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Curing Light Machine
Model / Reference
SKI-801, SKI-802, SKI-803, SKI-805, SKI-806, SKI-807, SKI-808
Primary DI / UDI-DI
06978811800109
Basic UDI-DI
697881180CLM001KV
EMDN Code
Q010299 Prosthetic dentistry devices - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047988
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Foshan Duoyimei Medical Instrument 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