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Human Chorionic Gonadotropin plus the hCG β-subunit Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. EUDAMED

Active European Union

Ref 100tests/kit, 50tests/kit, S2027E-200, S2027E-50, S2027E-150Model Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle ) 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kit

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719604494 Basic UDI-DIDate23 May 2025RegisteredStatusActive

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  • Withdrawn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
Human Chorionic Gonadotropin plus the hCG β-subunit Chemiluminescence Immunoassay Kit
Model / Reference
Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit, 100tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit, 50tests/kit, S2027E-200, S2027E-50, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit, S2027E-150, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle ) 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kit
Primary DI / UDI-DI
06972719604494, 06972719602216, 06955792738492, 06955792738454, 06972719604487, 06972719602230, 06955792738485, 06972719606511, 06972719606498, 06972719606528
Basic UDI-DI
B-06972719604494, B-06972719602216, B-06955792738492, B-06955792738454, B-06972719604487, B-06972719602230, B-06955792738485, B-06972719606511, B-06972719606498, B-06972719606528
EMDN Code
W0102050206 B- human chorionic gonadotropin (incl. subunit)
Device Class
Class IVD General
Market of Registration
Hungary
France

Manufacturer details

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

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Properties

  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Microbial Substances NoEUDAMEDYesEUDAMED
  • Reagent
  • Professional Testing NoEUDAMEDYesEUDAMED

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No