D-Dimer Control

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

Ref 105-046735-00Model 105-046778-00, 105-046779-00

EMDN W0103020702

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69449040AB74000565X Basic UDI-DI	Date23 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

Device Name: D-Dimer (CLIA)
Model / Reference: 105-046778-00, 105-046779-00, 105-046735-00

Primary DI / UDI-DI: 06903053079839
Basic UDI-DI: 69449040AB74000565X
EMDN Code: W0103020702 Control plasma for haemostasis

Device Class: Class C
Market of Registration: Denmark

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

Animal Tissues
Reagent
Professional Testing

Other properties (8)

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

Sources (1)

EUDAMED 06903053079839|69449040AB74000565X 61 fields · synced 24 Oct 2026