Apolipoprotein B Assay Kit (Immunoturbidimetric Method)

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

Ref DTSH060610Model R1: 60 mL×4; R2: 15 mL×4 EMDN W0102010403

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06975225462282 Basic UDI-DI	Date22 Feb 2023Registered	StatusActive

Coverage

1 jurisdiction

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Withdrawn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: Apolipoprotein B Assay Kit (Immunoturbidimetric Method)
Model / Reference: R1: 60 mL×4, R2: 15 mL×4, DTSH060610

Primary DI / UDI-DI: 06975225462282
Basic UDI-DI: B-06975225462282
EMDN Code: W0102010403 Apolipoprotein b

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 & 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 7dc406b9-68dd-4a8d-9c97-6935cfd593cc 61 fields · synced 24 Oct 2026