Chemistry Analyzer

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED

Ref BS-4000Model BS-5000,BS-5200,BS-5400,BS-5600,BS-4200,BS-4000

EMDN W0201010108

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69449040AB400000527 Basic UDI-DI	Date21 Apr 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: BS-5000, BS-5200, BS-5400, BS-5600, BS-4200, BS-4000

Primary DI / UDI-DI: 06903053121668
Basic UDI-DI: 69449040AB400000527
EMDN Code: W0201010108 CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)

Device Class: Class A
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000014156
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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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 4a448e23-a1d8-4bfd-a005-7b2570e29337 61 fields · synced 22 Oct 2026