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UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Koios DS

UDI-DI 00860002545714Basic UDI-DI 086000254573XTF

Class IIb · MDR · Koios Medical Inc.

Identification
Model
Koios DS 3.8
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

28620136087-01

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2023-06-05 · Expiry 2027-08-09

Scope not stated in certificate data.

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

Manufacturer

Koios Medical Inc.

SRN US-MF-000020636

US · New York

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

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/koios-ds-5714 · UDI page: /udi/00860002545714

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