Urine formed element control

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

Ref 105-043949-00Model Please see UDI-DI for details

EMDN W010106020601

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69449040AB760000364 Basic UDI-DI	Date3 Jun 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Urine formed element control、Urine Sediment Calibrator
Model / Reference: Please see UDI-DI for details, 105-043949-00

Primary DI / UDI-DI: 06903053070744
Basic UDI-DI: 69449040AB760000364
EMDN Code: W010106020601 Urine testing controls

Device Class: Class B
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

Reagent
Professional Testing

Other properties (9)

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

Sources (1)

EUDAMED abbf5905-aa8f-4ff8-bc2a-1003c91697e0 61 fields · synced 22 Oct 2026