Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

BioniQ implant – tapered

UDI-DI 08595573003135Basic UDI-DI 85955730001XJ

Class IIb · MDR · LASAK s.r.o.

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Identification

Model: BioniQ implant – straight, BioniQ implant – tapered, BioniQ implant Plus – straight
EMDN: P01020101
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

SRN CZ-MF-000031907

CZ · Hloubětín, Praha 9

manufacturer

Related UDI-DIs

BioniQ implant Plus – straight 08595573003258
BioniQ implant Plus – straight 08595573003197
BioniQ implant Plus – straight 08595573003340
BioniQ implant Plus – straight 08595573003289
BioniQ implant Plus – straight 08595573003265
BioniQ implant Plus – straight 08595573003333
BioniQ implant Plus – straight 08595573003319
BioniQ implant Plus – straight 08595573003296
BioniQ implant Plus – straight 08595573003302
BioniQ implant Plus – straight 08595573003234
BioniQ implant Plus – straight 08595573003210
BioniQ implant Plus – straight 08595573003227

Showing 12 of 47 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/bioniq-implant-tapered-3135 · UDI page: /udi/08595573003135

All devices from LASAK s.r.o.

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