Auto-Chemistry Analyzer

by Dirui Industrial Co., Ltd China EUDAMED

Ref 3028894Model CS-1400i

EMDN W0201010107

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69422022W020101010703D06A Basic UDI-DI	Date21 Sep 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference: CS-1400i, 3028894

Primary DI / UDI-DI: 06942202267772
Basic UDI-DI: 69422022W020101010703D06A
EMDN Code: W0201010107 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)

Device Class: Class B
Market of Registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000001891
Authorised representative: Emergo Europe B.V. NL-AR-000000116

Other devices from Dirui Industrial Co., Ltd

Free Prostate Specific Antigen Detection Kit ( Chemiluminescence Immunoassay )

Class C
Fibrinogen Detection Kit (Coagulation Assay)

Class C
ISE Reference Solution

Class A
Urea Reagent Kit (Urease-Glutamate Dehydrogenase Assay)

Class B
Anti-streptolysin O Reagent Kit(Latex Immunoturbidimetric Assay)

Class B
Creatine Kinase MB Detection Kit (Chemiluminescence Immunoassay)

Class C

See all devices from Dirui Industrial Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records

Surgical Instrument

Other properties (10)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Reagent: No
Self Testing: No
Near-Patient Testing: No
Professional Testing: No
Companion Diagnostics: No
New Device: No

Sources (1)

EUDAMED 06942202267772|69422022W020101010703D06A 61 fields · synced 24 Oct 2026