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RS85

by Samsung Medison Co., Ltd South Korea EUDAMED

Ref N/A

EMDN Z11040101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880972578USS001X6 Basic UDI-DIDate3 Nov 2022RegisteredStatusActive

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
Ultrasound Scanner
Model / Reference
N/A
Primary DI / UDI-DI
08800290035001
Basic UDI-DI
880972578USS001X6
EMDN Code
Z11040101 Internal ultrasound scanners
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000011620
Authorised representative
Samsung Electronics GmbH DE-AR-000007005

Other devices from Samsung Medison Co., Ltd.

See all devices from Samsung Medison 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 2372e7ee-c8d3-47de-b097-8909e587cd0c 61 fields · synced 22 Oct 2026