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Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

BioniQ implant Plus – straight

UDI-DI 08595573003333Basic UDI-DI 85955730001XJ

Class IIb · MDR · LASAK s.r.o.

Identification
Model
BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Plus – straight
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2023-MDR/TD-037

EU technical documentation assessment · 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.

2023-MDR/QS-037

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

LASAK s.r.o.

SRN CZ-MF-000031907

CZ · Hloubětín, Praha 9

manufacturer

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Canonical device page: /device/bioniq-implant-plus-straight-3333 · UDI page: /udi/08595573003333

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