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Fully-Auto Chemiluminescence Immunoassay Analyzer

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref A6I EMDN W02010199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6972719600091BJ Basic UDI-DIDate6 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Fully-Auto Chemiluminescence Immunoassay Analyzer
Model / Reference
A6I
Primary DI / UDI-DI
06972719603725
Basic UDI-DI
6972719600091BJ
EMDN Code
W02010199 Chemistry instruments - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000024838
Authorised representative
Sungo Cert GmbH DE-AR-000010869

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 5813c063-094e-4d10-9537-bd2990e1e17d 61 fields · synced 22 Oct 2026