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Cystatin C Assay Kit (Latex Immunoturbidimetric Method)

by Da Te Bioengineering Technology Co., LTD. EUDAMED

Active European Union

Ref DTSH030507CModel R1: 45 mL×3; R2: 45 mL×1; Calibrator: 0.5 mL × 5; quality control: 1 mL × 2

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975225463210 Basic UDI-DIDate3 Mar 2023RegisteredStatusActive

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  • Withdrawn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
Cystatin C Assay Kit (Latex Immunoturbidimetric Method)
Model / Reference
R1: 45 mL×3, R2: 45 mL×1, Calibrator: 0.5 mL × 5, quality control: 1 mL × 2, DTSH030507C
Primary DI / UDI-DI
06975225463210
Basic UDI-DI
B-06975225463210
EMDN Code
W0102019008 Cystatin c
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000028832
Authorised representative
Lotus NL B.V. NL-AR-000000121

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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