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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Massive abutment, BioniQ

UDI-DI 08595573009908Basic UDI-DI 85955730028Y6

Class IIb · MDR · LASAK s.r.o.

Identification
Model
Premill abutment, BioniQ, AG – Ti; Premill abutment, BioniQ, NT – Ti; Massive abutment, BioniQ
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2023-MDR/TD-038/A

EU technical documentation assessment · unknown

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

Valid from 2025-06-10 · 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-038/A

EU quality management system · unknown

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

Valid from 2025-06-10 · 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

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/massive-abutment-bioniq-9908 · UDI page: /udi/08595573009908

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