Skip to content

Homocysteine Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. EUDAMED

Active European Union

Ref 50tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719606962 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  • Withdrawn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

Device Name
Homocysteine Chemiluminescence Immunoassay Kit
Model / Reference
Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit, 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit
Primary DI / UDI-DI
06972719606962, 06972719606016, 06972719606009
Basic UDI-DI
B-06972719606962, B-06972719606016, B-06972719606009
EMDN Code
W01021307 Homocysteine
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.

See all devices from Nanjing RealMind Biotech Co., Ltd. →

Properties

Show properties
  • 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