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Oral Mirror

by Foshan Linke Medical Instrument Co., Ltd China EUDAMED

Ref HM01Model HM01, HM02, HM03, HM04, HM05, HM06, HM07, HM08, HM-Y3, HM-Y5, HM-Y10, HM-Y27, HM-Y39, HM-A1, HM-A2

EMDN Q010504

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697883683OM001T2 Basic UDI-DIDate9 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Oral Mirror
Model / Reference
HM01, HM02, HM03, HM04, HM05, HM06, HM07, HM08, HM-Y3, HM-Y5, HM-Y10, HM-Y27, HM-Y39, HM-A1, HM-A2
Primary DI / UDI-DI
06978836835001
Basic UDI-DI
697883683OM001T2
EMDN Code
Q010504 Dentistry mirrors and stylets, single-use
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048246
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Foshan Linke Medical Instrument Co., Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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

Sources (1)

  • EUDAMED 4c2cc2fa-3fe0-4d99-a2d4-986c8741662f 61 fields · synced 22 Oct 2026