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Gastrin-17 Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. EUDAMED

Active European Union

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719602988 Basic UDI-DIDate23 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Gastrin-17 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
Primary DI / UDI-DI
06972719602988, 06972719604715
Basic UDI-DI
B-06972719602988, B-06972719604715
EMDN Code
W0102069001 Gastrin
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

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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