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Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Strep A Rapid Test Device

UDI-DI 06976081910016Basic UDI-DI 6976081918000000472W9

Class C · IVDR · Zhejiang QL Biotech Co., Ltd.

Identification
Model
IST-502s
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

6210573TD01

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-01-19 · Expiry 2031-01-01

Scope not stated in certificate data.

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

6210573CE01

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-01-19 · Expiry 2031-01-01

Scope not stated in certificate data.

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

Manufacturer

Zhejiang QL Biotech Co., Ltd.

SRN CN-MF-000034990

CN · Hangzhou

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-0016 · UDI page: /udi/06976081910016

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