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Test Card

by Chongqing NanFang Numerical ControlEquipment Co., Ltd. EUDAMED

Active European Union

Ref Test Card

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-697838332CSK-001RA Basic UDI-DIDate14 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Test Card
Model / Reference
Test Card
Primary DI / UDI-DI
D-697838332CSK-001RA
Basic UDI-DI
B-697838332CSK-001RA
EMDN Code
W010399 Haematology / haemostasis / immunohaematology / histology / cytology reagents - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000055985
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Chongqing NanFang Numerical ControlEquipment Co., Ltd.

Properties

  • 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
  • Professional Testing: No
  • Companion Diagnostics: No