Apolipoprotein B Kit (Turbidimetry Method)

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 3 variants

Ref 105-000838-00Model 105-000838-00、105-000877-00、105-004603-00

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number694490400041ApoB*******B8 Basic UDI-DI 06944904024943UDI-DI	Date19 Sep 2022Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference: 105-000838-00、105-000877-00、105-004603-00, 105-000838-00

Primary DI / UDI-DI: 06944904024943
Basic UDI-DI: 694490400041ApoB*******B8
EMDN Code: W0102010403 Apolipoprotein b

Device Class: Class B
EU 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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Class IIb
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Properties

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