Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Steradian Shield

UDI-DI 20853714008107Basic UDI-DI 0853714008SS0000W5

Class Is · MDR · Radux Devices, Inc.

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Identification

Model: —
EMDN: T0299
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

28620155493-03

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2025-04-28 · Expiry 2027-10-08

Scope not stated in certificate data.

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

Manufacturer

Radux Devices, Inc.

SRN US-MF-000034745

US · Fridley

manufacturer

Authorised representative: MedEnvoy Global BV (NL-AR-000024028)

Related UDI-DIs

Steradian Shield 00853714008080
Steradian Shield 00853714008103
Steradian Shield 10853714008087
Steradian Shield 10853714008100
Steradian Shield 20853714008084

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/steradian-shield-8107 · UDI page: /udi/20853714008107

All devices from Radux Devices, Inc.

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