Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Gonorrhea Rapid Test

UDI-DI 06942598231371Basic UDI-DI 6970277510015DY5

Class C · IVDR · Hangzhou Alltest Biotech.Co.,Ltd.

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Identification

Model: —
EMDN: W0105090199
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

EU-TDA-FI-51326-800081-2026

EU technical documentation assessment · unknown

Notified body: Kiwa Sertio Oy (3018)

Valid from 2026-07-09 · Expiry 2031-04-16

Scope not stated in certificate data.

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

Manufacturer

Hangzhou Alltest Biotech.Co.,Ltd.

SRN CN-MF-000010710

CN · Hangzhou

manufacturer

Authorised representative: MedNet EC-REP GmbH (DE-AR-000000002)

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Canonical device page: /device/gonorrhea-rapid-test-1371 · UDI page: /udi/06942598231371

All devices from Hangzhou Alltest Biotech.Co.,Ltd.

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