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Fully automated sample processing system

by Changchun Sunostik Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref Milestone 2

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697670497101PA Basic UDI-DIDate23 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
Milestone 2
Primary DI / UDI-DI
06976704971011
Basic UDI-DI
697670497101PA
Direct Marketing DI
06976704971011
EMDN Code
W02020199 Cell counting instruments - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000051464
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Changchun Sunostik Medical Technology Co., Ltd.

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No