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Intraoral Scanner

by Shenzhen Lodden Medical Technology Co., Ltd. China EUDAMED

Ref Heyinscan S5Model Heyinscan S3,Heyinscan S5,Heyinscan S7,Heyinscan W1,Heyinscan W2,Heyinscan W3, EMDN Z11030402

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697795840ScannerGU Basic UDI-DIDate29 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Intraoral Scanner
Model / Reference
Heyinscan S3, Heyinscan S5, Heyinscan S7, Heyinscan W1, Heyinscan W2, Heyinscan W3
Primary DI / UDI-DI
06977958400012
Basic UDI-DI
697795840ScannerGU
EMDN Code
Z11030402 Systems for intraoral digital videoradiography
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000044245
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Lodden Medical Technology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED bf8fecf1-e0a2-4e0b-996c-27ac5dfa77a2 61 fields · synced 25 Oct 2026