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Snapshot 2026-10-12 · Link to EUDAMED

Legacy device

Carbohydrate Antigen 19-9（CA19-9）Assay Kit（Chemiluminescent Immunoassay）

UDI-DI 06937287300353Basic UDI-DI B-06937287300353

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

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Identification

Model: 100 tests/kit
EMDN: W0102030103
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/carbohydrate-antigen-19-9-ca19-9-assay-kit-chemiluminescent--0353 · UDI page: /udi/06937287300353

All devices from Shenzhen AmTech Bioengineering Ltd., Inc.

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