Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

RADIFOCUS Optitorque

UDI-DI 08935221221397Basic UDI-DI 498735026RCRHPA

Class III · MDR · Terumo Corporation

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Identification

Model: —
EMDN: C0104010101
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

IZ 1485480-1

EU technical documentation assessment · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2022-12-19 · Expiry 2027-12-18

Scope not stated in certificate data.

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

Manufacturer

Terumo Corporation

SRN JP-MF-000017478

JP · Shibuya-ku, Tokyo

manufacturer

Authorised representative: TERUMO EUROPE N.V. (BE-AR-000001433)

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Showing 12 of 344 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/radifocus-optitorque-1397 · UDI page: /udi/08935221221397

All devices from Terumo Corporation

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