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Insulin Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref 100tests/kit, 50tests/kit, 215160009Model 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 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit, Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EMDN W0102060103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719605132 Basic UDI-DIDate22 May 2025RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Insulin 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, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit, 215160009, Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit, Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit
Primary DI / UDI-DI
06972719605132, 06972719602575, 06972719601561, 06972719601110, 06972719602568, 06972719605149
Basic UDI-DI
B-06972719605132, B-06972719602575, B-06972719601561, B-06972719601110, B-06972719602568, B-06972719605149
EMDN Code
W0102060103 Insulin
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 (6)

  • EUDAMED fab3469d-d28c-4eda-8dd1-4e9aa373b1e2 61 fields · synced 22 Oct 2026
  • EUDAMED 06972719602575|B-06972719602575 61 fields · synced 17 May 2026
  • EUDAMED 06972719601561|B-06972719601561 61 fields · synced 17 May 2026
  • EUDAMED 06972719601110|B-06972719601110 61 fields · synced 18 May 2026
  • EUDAMED 06972719602568|B-06972719602568 61 fields · synced 18 May 2026
  • EUDAMED 06972719605149|B-06972719605149 61 fields · synced 19 May 2026