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Intraoral Scanner

by Changzhou Sifary Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref 7680013Model Helios 500, Helios 620,Helios 630, Helios 640, Helios 650,Helios 660, Helios 670, MyScanner, SCAN-MI PRO

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697259778EM002MJ Basic UDI-DIDate29 Nov 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Helios 500, Helios 620, Helios 630, Helios 640, Helios 650, Helios 660, Helios 670, MyScanner, SCAN-MI PRO, 7680013
Primary DI / UDI-DI
06941877809966
Basic UDI-DI
697259778EM002MJ
Direct Marketing DI
06941877809966
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000010405
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Changzhou Sifary Medical Technology Co., Ltd.

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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