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Snapshot 2026-10-13 · Link to EUDAMED

Legacy device

Glycated Hemoglobin （HbA1c）Assay Kit (Latex Immunoturbidimetric Method)

UDI-DI 06974760129643Basic UDI-DI B-06974760129643

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

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Identification

Model: R1: 1×60 mL, R2: 1×20 mL, Hemolytic agent: 2×70 mL
EMDN: W01010214
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/glycated-hemoglobin-hba1c-assay-kit-latex-immunoturbidimetri-9643 · UDI page: /udi/06974760129643

All devices from Shenzhen AmTech Bioengineering Ltd., Inc.

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