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LED Curing Light

by Foshan Topmed Dental Co., Ltd EUDAMED

Active European Union

Ref TOPCURE B-EModel TOPCURE X、TOPCURE、TOPCURE B-U、TOPCURE B-E、TOPCURE B-24V、TM-E0005、TM-E0007、TM-E0008

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698014095LCLPR Basic UDI-DIDate26 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
LED Curing Light
Model / Reference
TOPCURE X、TOPCURE、TOPCURE B-U、TOPCURE B-E、TOPCURE B-24V、TM-E0005、TM-E0007、TM-E0008, TOPCURE B-E
Primary DI / UDI-DI
06980140953043
Basic UDI-DI
698014095LCLPR
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057253
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Foshan Topmed Dental Co., Ltd

See all devices from Foshan Topmed Dental 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