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C-Reactive Protein Assay Kit (Immunoturbidimetric Method)

by Da Te Bioengineering Technology Co., LTD. China EUDAMED

Ref DTSH050109Model R1: 60 mL×2; R2: 15 mL×2 EMDN W01021109

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975225462114 Basic UDI-DIDate22 Feb 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
C-Reactive Protein Assay Kit (Immunoturbidimetric Method)
Model / Reference
R1: 60 mL×2, R2: 15 mL×2, DTSH050109
Primary DI / UDI-DI
06975225462114
Basic UDI-DI
B-06975225462114
EMDN Code
W01021109 C-reactive protein
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

Other devices from Da Te Bioengineering Technology Co., LTD.

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 5c2d3ca2-9579-4c1f-8bed-1c38fd345776 61 fields · synced 24 Oct 2026