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HBsAg Positive Control

Certificate valid

Snapshot 2026-11-02 · Link to EUDAMED

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Class D · IVDR · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Identification

Model
HBsAg121, HBsAg122
Issuing agency
GS1
Device status
active
Sterile
No

Certificates

V76 044751 0357

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-10-14 · Expiry 2031-10-13

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

SRN CN-MF-000014156

CN · Shenzhen

manufacturer

Authorised representative: Shanghai International Holding Corp. GmbH(Europe) (DE-AR-000000001)

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Showing 12 of 13 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hbsag-positive-control-5804 · UDI page: /udi/06936415905804

All devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.