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Homocysteine（HCY）Reagent Kit (Enzymatic Cycling Method)

by URIT Medical Electronic Co., Ltd. EUDAMED

Active European Union

Ref "REF: U83582015M, U83582030M, U83589045M, U83585015M, U83511020M, U83520030M"

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-6-16T Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Homocysteine（HCY）Reagent Kit (Enzymatic Cycling Method)
Model / Reference
"REF: U83582015M, U83582030M, U83589045M, U83585015M, U83511020M, U83520030M"
Primary DI / UDI-DI
D-6-16T
Basic UDI-DI
B-6-16T
EMDN Code
W01021307 Homocysteine
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000011840
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

Show properties
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No