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AcuteckTM Blood Glucose Monitoring System

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

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Class C · IVDR · Assure Tech. (Hangzhou) Co., Ltd.

Identification

Model
—
Issuing agency
GS1
Device status
active
Sterile
No

Certificates

IX 2074650-2

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2026-03-17 · Expiry 2031-03-16

Scope not stated in certificate data.

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

Manufacturer

Assure Tech. (Hangzhou) Co., Ltd.

SRN CN-MF-000002170

CN · Hangzhou, Zhejiang

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

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AcuteckTM Blood Glucose Test Strips06952804823368
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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/acutecktm-blood-glucose-monitoring-system-9446 · UDI page: /udi/06952804819446

All devices from Assure Tech. (Hangzhou) Co., Ltd.