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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

STANDARD™ M10 Flu/RSV/SARS-CoV-2

UDI-DI 08800111722158Basic UDI-DI 88001117IPBA01MA03WR

Class B · IVDR · SD Biosensor Inc.

Identification
Model
M10-CVFR-02
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

V76 075369 0071

EU technical documentation assessment · valid

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2025-07-09 · Expiry 2030-07-08

Scope not stated in certificate data.

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

Manufacturer

SD Biosensor Inc.

SRN KR-MF-000009168

KR · Gyeonggi-do, Suwon-si

manufacturer

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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/standardtm-m10-flu-rsv-sars-cov-2-2158 · UDI page: /udi/08800111722158

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