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UDI Compass

Cancer Antigen 15-3（CA15-3）Assay Kit（Chemiluminescent Immunoassay）

No Certificate FoundLegacy device

Snapshot 2026-11-02 · Link to EUDAMED

UDI-DI 06937287300407Basic UDI-DI B-06937287300407

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Unknown class · IVDD (legacy) · Shenzhen AmTech Bioengineering Ltd., Inc.

Identification

Model
100 tests/kit
Issuing agency
GS1
Device status
active
Sterile
No

Manufacturer

Shenzhen AmTech Bioengineering Ltd., Inc.

SRN CN-MF-000043067

CN · Shenzhen

manufacturer

Authorised representative: SUNGO Europe B.V. (NL-AR-000000247)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/cancer-antigen-15-3-ca15-3-assay-kit-chemiluminescent-immuno-0407 · UDI page: /udi/06937287300407

All devices from Shenzhen AmTech Bioengineering Ltd., Inc.