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Intraoral scanner

by Ownsmile Biotechnology Co., Limited Hong Kong EUDAMED

Ref OS-5SModel 04897150810032

EMDN Z11030402

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number489715081IntraoralsLV Basic UDI-DIDate7 Nov 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
Intraoral scanner
Model / Reference
04897150810032, OS-5S
Primary DI / UDI-DI
04897150810032
Basic UDI-DI
489715081IntraoralsLV
EMDN Code
Z11030402 Systems for intraoral digital videoradiography
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
HK-MF-000046636
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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 51ab1fd6-5360-423c-9b61-0efe2f24ff1c 61 fields · synced 22 Oct 2026