Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

One Step hCG Urine Test

UDI-DI 06970725815019Basic UDI-DI 697072581B1HCG00N25S11CRP

Class B · IVDR · Atlas Link Technology Co., Ltd.

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Identification

Model: Cassette
EMDN: W0102160302
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

IVDR 783876

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-07-29 · Expiry 2030-10-14

Scope not stated in certificate data.

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

Manufacturer

Atlas Link Technology Co., Ltd.

SRN CN-MF-000021058

CN · Langfang

manufacturer

Authorised representative: Medical Technology Promedt Consulting GmbH (DE-AR-000000085)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/one-step-hcg-urine-test-5019 · UDI page: /udi/06970725815019

All devices from Atlas Link Technology Co., Ltd.

Scan an inventory CSV