Skip to content

Prealbumin Assay Kit (Immunoturbidimetric Method)

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

Ref DTSH021307CModel R1: 45 mL×3; R2: 45 mL×1; Calibrator: 1 mL×1 EMDN W0102010405

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975225463579 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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Prealbumin Assay Kit (Immunoturbidimetric Method)
Model / Reference
R1: 45 mL×3, R2: 45 mL×1, Calibrator: 1 mL×1, DTSH021307C
Primary DI / UDI-DI
06975225463579
Basic UDI-DI
B-06975225463579
EMDN Code
W0102010405 Lipoprotein ( a )
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

Related devices

Category: Apolipoprotein B (Apo B) IVD, reagent

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

See all devices from Da Te Bioengineering Technology Co., LTD. →

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 afef9688-6cb7-41dd-b4e6-c8b189f1aa12 61 fields · synced 24 Oct 2026