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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Human Luteinizing Hormone Rapid Test (25mIU)

UDI-DI 06952804838065Basic UDI-DI 69528048A044100XN

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

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

2279233CE01

EU quality management system · unknown

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

Valid from 2024-09-10 · Expiry 2029-09-01

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

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/human-luteinizing-hormone-rapid-test-25miu-8065 · UDI page: /udi/06952804838065

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