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Laminin Assay kit(Chemiluminescence Immunoassay Method）

by Shenzhen Dake Medical Technology Co., Ltd China EUDAMED

Ref 25 testsModel 25 tests，50 tests，2×50 tests，100 tests，2×100 tests EMDN W0102039006

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697846523ProteinB10R9 Basic UDI-DIDate15 May 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Trade Name
Laminin Assay kit(Chemiluminescence Immunoassay Method）
D-Dimer Assay kit Assay kit(Chemiluminescence Immunoassay Method）
Model / Reference
25 tests，50 tests，2×50 tests，100 tests，2×100 tests, 25 tests
Primary DI / UDI-DI
06978465235654, 06978465238020
Basic UDI-DI
697846523ProteinB10R9, 697846523OtherC01YT
EMDN Code
W0102039006, W0103020503
Device Class
Class B
Class C
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047336
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

Other devices from Shenzhen Dake Medical Technology Co., Ltd

See all devices from Shenzhen Dake Medical Technology Co., Ltd →

Properties & raw data

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

Sources (2)

  • EUDAMED bb30468c-1a35-4bfb-a7f5-aa05dd42b21f 61 fields · synced 23 Oct 2026
  • EUDAMED 06978465238020|697846523OTHERC01YT 61 fields · synced 24 Oct 2026