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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Strep A Rapid Test

UDI-DI 06976202760018Basic UDI-DI 697620276GISTA000014E

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

Identification
Model
GISTA-702H
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

IX 2566030-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2025-03-13 · Expiry 2030-03-12

Scope not stated in certificate data.

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

Manufacturer

Zhejiang Greylynx Biotech Co., Ltd.

SRN CN-MF-000032462

CN · Hangzhou, Zhejiang

manufacturer

Authorised representative: Lotus NL B.V. (NL-AR-000000121)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/strep-a-rapid-test-0018 · UDI page: /udi/06976202760018

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