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iNSiGHT C510

by OsteoSys Co., Ltd. South Korea EUDAMED

Ref iNSiGHT C510Model iNSiGHT C510

EMDN Z11900103

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number088000084DXAD5N Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
iNSiGHT C510
Primary DI / UDI-DI
08800008400121
Basic UDI-DI
088000084DXAD5N
Direct Marketing DI
08800008400121
EMDN Code
Z11900103 X–ray bone densitometers
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

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

Other devices from OsteoSys Co., Ltd.

See all devices from OsteoSys Co., Ltd. →

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 08800008400121|088000084DXAD5N 61 fields · synced 24 Oct 2026