Unknown / Not in EUDAMED

Snapshot 2026-10-17 · Link to EUDAMED

Examedin® FAST Control solution (Normal)

UDI-DI 08800323058021Basic UDI-DI 880911590OGSH01GL4A

Class C · IVDR · OSANG Healthcare Co., Ltd

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Identification

Model: OG-SH01-GL
EMDN: W010106010801
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

IVDR 793252

EU technical documentation assessment · unknown

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

Valid from 2026-09-15 · Expiry 2029-03-27

Scope not stated in certificate data.

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

Manufacturer

OSANG Healthcare Co., Ltd

SRN KR-MF-000032605

KR · Anyang-si, Gyeonggi-do

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

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Showing 12 of 49 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/examedin-fast-control-solution-normal-8021 · UDI page: /udi/08800323058021

All devices from OSANG Healthcare Co., Ltd

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