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Colloidal gold immunochromatography reader

by Suzhou Helmen Precision Insturments Co., Ltd EUDAMED

Active European Union

Ref GIC-H1WModel GIC-S100、GIC-H1W、GIC-H1N、GIC-Q100、GIC-Q100N、GIC-M6、GIC-M6G、GIC-H2、GIC-A1600、GIC-H0、GIC-H0mini

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697360215GICP5 Basic UDI-DIDate6 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  • Withdrawn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

Model / Reference
GIC-S100、GIC-H1W、GIC-H1N、GIC-Q100、GIC-Q100N、GIC-M6、GIC-M6G、GIC-H2、GIC-A1600、GIC-H0、GIC-H0mini, GIC-H1W
Primary DI / UDI-DI
06973602150722
Basic UDI-DI
697360215GICP5
Direct Marketing DI
06973602150722
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

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

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Properties

Show properties
  • Near-Patient Testing
  • Companion Diagnostics
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Professional Testing: No
  • New Device: No