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Fully Automated Agglutination Detection Analyzer

by Chongqing NanFang Numerical ControlEquipment Co., Ltd. EUDAMED

Active European Union

Ref ART1001

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-697838332NJCY-001BR 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  • Withdrawn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
Fully Automated Agglutination Detection Analyzer
Model / Reference
ART1001
Primary DI / UDI-DI
D-697838332NJCY-001BR
Basic UDI-DI
B-697838332NJCY-001BR
EMDN Code
W0299 IVD instruments - other
Device Class
Class IVD General
Market of Registration
France

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

  • Professional Testing
  • Surgical Instrument

Other properties (8)

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