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Alpha-Fetoprotein Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref 215090009Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 50tests/kit

EMDN W0102039001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719600663 Basic UDI-DIDate10 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Alpha-Fetoprotein Chemiluminescence Immunoassay Kit
Model / Reference
Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 50tests/kit, 215090009
Primary DI / UDI-DI
06972719600663
Basic UDI-DI
B-06972719600663
EMDN Code
W0102039001 Alphafetoprotein
Device Class
Class IVD General
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000024838
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Nanjing RealMind Biotech Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 7a36eacd-a1c4-4ba7-a200-6efc0adc0b0c 61 fields · synced 23 Oct 2026