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Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

System 4 Pro

UDI-DI 00718175004005Basic UDI-DI 07181752014S

Class IIa · MDR · Biodex Medical Systems

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

28620195564

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2024-11-06 · Expiry 2028-12-02

Scope not stated in certificate data.

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

Manufacturer

Biodex Medical Systems

SRN US-MF-000028834

US · Shirley

manufacturer

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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/system-4-pro-4005 · UDI page: /udi/00718175004005

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