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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

H.Pylori Antigen Test Kit

UDI-DI 06952062711643Basic UDI-DI 69520627J016LB

Class C · IVDR · ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

Identification
Model
Cassette Tube Strip
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

EU-TDA-FI-20642-800030-2025-1

EU technical documentation assessment · unknown

Notified body: Kiwa Sertio Oy (3018)

Valid from 2026-06-09 · Expiry 2030-03-21

Scope not stated in certificate data.

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

Manufacturer

ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

SRN CN-MF-000018785

CN · Hefei, Anhui

manufacturer

Authorised representative: Mega Eurostar Sp. z o.o. (PL-AR-000042730)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/h-pylori-antigen-test-kit-1643 · UDI page: /udi/06952062711643

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