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Chemiluminescence Immunoassay Analyzer

by Shenzhen Increcare Biotech Co., Ltd China EUDAMED

Ref GS1Model Shine i8900

EMDN W0201020104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697514017Shinei8900JC Basic UDI-DIDate5 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Shine i8900, GS1
Primary DI / UDI-DI
06975140170811
Basic UDI-DI
697514017Shinei8900JC
EMDN Code
W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000027299
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Increcare Biotech Co., Ltd

See all devices from Shenzhen Increcare Biotech Co., Ltd →

Properties & raw data

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

Sources (1)

  • EUDAMED d811346a-3f29-422d-8752-5f7a0dab6e23 61 fields · synced 22 Oct 2026