Chemistry Analyzer

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

Ref CMD 1000i X1Model BS-1000M、BS-1100M

EMDN W0201010107

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69449040AB4000001ZU Basic UDI-DI	Date15 Apr 2024Registered	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: BS-1000M、BS-1100M, CMD 1000i X1

Primary DI / UDI-DI: 06903053096379
Basic UDI-DI: 69449040AB4000001ZU
EMDN Code: W0201010107 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 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

Professional Testing
Surgical Instrument

Other properties (9)

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

Sources (1)

EUDAMED ccfcc472-cfd4-48c5-b9b5-e51a786345b1 61 fields · synced 24 Oct 2026