Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Insertion wrench BioniQ for guided surgery (GS)

UDI-DI 08595573002398Basic UDI-DI 85955730047YA

Class I · MDR · LASAK s.r.o.

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Identification

Model: Insertion wrench BioniQ for guided surgery; Insertion wrench
EMDN: L159099
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: Yes

Certificates

2023-MDR/QS-041

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2023-10-27 · Expiry 2028-10-27

Scope not stated in certificate data.

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

Manufacturer

SRN CZ-MF-000031907

CZ · Hloubětín, Praha 9

manufacturer

Related UDI-DIs

Insertion wrench BioniQ – extra short 08595573002268
Insertion wrench BioniQ – long 08595573002251

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/insertion-wrench-bioniq-for-guided-surgery-gs-2398 · UDI page: /udi/08595573002398

All devices from LASAK s.r.o.

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