Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

AcuteckTM Blood Glucose Test Meter

UDI-DI 06952804823313Basic UDI-DI 69528048GOP-101ProSK85

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

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Identification

Model: —
EMDN: W0201060102
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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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/acutecktm-blood-glucose-test-meter-3313 · UDI page: /udi/06952804823313

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

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