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Pregnancy-associated Plasma Protein A Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit

EMDN W0102050210

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719607204 Basic UDI-DIDate22 May 2026RegisteredStatusActive

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 24 Oct 2026

Device Name
Pregnancy-associated Plasma Protein A Chemiluminescence Immunoassay Kit
Model / Reference
Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit, 50tests/kit
Primary DI / UDI-DI
06972719607204
Basic UDI-DI
B-06972719607204
EMDN Code
W0102050210 Pregnancy associated plasma protein - a (downs)
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 75bf7bd6-1d2a-41ac-838b-f7154aaeb02f 61 fields · synced 24 Oct 2026