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Intraoral Scanner

by Hangzhou Tzin TECH CO;LTD EUDAMED

Active European Union

Ref /Model C5

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697840619C32R Basic UDI-DIDate9 Jun 2025RegisteredStatusActive

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  • Withdrawn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
Intraoral Scanner
Model / Reference
C5, /
Primary DI / UDI-DI
06978406190004
Basic UDI-DI
697840619C32R
EMDN Code
Z11030402 Systems for intraoral digital videoradiography
Device Class
Class I
Market of Registration
Luxembourg

Manufacturer details

EUDAMED SRN
CN-MF-000048065
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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