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Certificate valid

Snapshot 2026-10-18 · Link to EUDAMED

Strep A Rapid Test Device

UDI-DI 06952804804558Basic UDI-DI 69528048A463101ZT

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

Identification
Model
Strip, Device
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IX 2074650-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2024-12-27 · Expiry 2029-06-12

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)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/strep-a-rapid-test-device-4558 · UDI page: /udi/06952804804558

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