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Aldosterone Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref 100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kit EMDN W0102060201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719607488 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Aldosterone Chemiluminescence Immunoassay Kit
Model / Reference
Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit, 100tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kit
Primary DI / UDI-DI
06972719607488, 06972719607495, 06972719607471
Basic UDI-DI
B-06972719607488, B-06972719607495, B-06972719607471
EMDN Code
W0102060201 Aldosterone
Device Class
Class IVD General
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000024838
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

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 (3)

  • EUDAMED 0da45028-0ac5-49d2-8482-01d5b44a0580 61 fields · synced 24 Oct 2026
  • EUDAMED 06972719607495|B-06972719607495 61 fields · synced 11 Jul 2026
  • EUDAMED 06972719607471|B-06972719607471 61 fields · synced 20 Jul 2026