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Curing light

by Guangzhou Conghua Shenghua Industry Co.Ltd.

Ref XliteModel Xlite2-W、Xlite2-B、Xlite2-3-W、Xlite2-3-B、Xlite2-3-R、Xlite2-3-G、Xlite3-W、Xlite3-B、Xlite3-G、Xlite3-R、Xlite4、Xlite4 Plus、Xlite6-B、Xlite6-G、Xlite7、Blue、Blue Max

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698009364Xlite001RA Basic UDI-DI 06980093640014UDI-DIDate7 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Xlite2-W、Xlite2-B、Xlite2-3-W、Xlite2-3-B、Xlite2-3-R、Xlite2-3-G、Xlite3-W、Xlite3-B、Xlite3-G、Xlite3-R、Xlite4、Xlite4 Plus、Xlite6-B、Xlite6-G、Xlite7、Blue、Blue Max, Xlite
Primary DI / UDI-DI
06980093640014
Basic UDI-DI
698009364Xlite001RA
EMDN Code
Q010299 Prosthetic dentistry devices - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000055524
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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