Premill abutment, BioniQ, AG – CoCr

Class IIb · MDR · LASAK s.r.o.

Identification

Model: Premill abutment, BioniQ, AG – CoCr; Premill abutment, BioniQ, NT – CoCr
EMDN: P01020180
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

SRN CZ-MF-000031907

CZ · Hloubětín, Praha 9

manufacturer

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