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Dry Fluorescence Immunoassay Analyzer

by Suzhou Helmen Precision Insturments Co., Ltd China EUDAMED

Ref FIC-M2Model FIC-H1W、FIC-H1N、FIC-Q100、FIC-Q100N、FIC-H2、FIC-S100、FIC-A1600、FIC-M6、FIC-M6G、FIC-H0、FIC-H0mini、FIC-M2、FIC-M2NT EMDN W0201020201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697360215FICNY Basic UDI-DIDate5 Sep 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
FIC-H1W、FIC-H1N、FIC-Q100、FIC-Q100N、FIC-H2、FIC-S100、FIC-A1600、FIC-M6、FIC-M6G、FIC-H0、FIC-H0mini、FIC-M2、FIC-M2NT, FIC-M2
Primary DI / UDI-DI
06973602151415
Basic UDI-DI
697360215FICNY
Direct Marketing DI
06973602151415
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000002230
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Suzhou Helmen Precision Insturments Co., Ltd

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Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • New Device: No

Sources (1)

  • EUDAMED cbf9a353-bfe6-47f4-80be-d31be54c9dc0 61 fields · synced 23 Oct 2026