Skip to content

Sonost-3000

by OsteoSys Co., Ltd. South Korea EUDAMED

Ref SONOST-3000

EMDN Z11900102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number088000084UBDA62 Basic UDI-DIDate8 Sep 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

Model / Reference
SONOST-3000
Primary DI / UDI-DI
08800008400046
Basic UDI-DI
088000084UBDA62
Direct Marketing DI
08800008400046
EMDN Code
Z11900102 Ultrasound bone densitometers
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000010177
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 6be62698-d357-4863-9633-d87b95070c30 61 fields · synced 22 Oct 2026