Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Uni-Base, BioniQ, indexed, wide

UDI-DI 08595573014643Basic UDI-DI 85955730026Y2

Class IIb · MDR · LASAK s.r.o.

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Identification

Model: Uni-Base, BioniQ; Uni-Base AN, BioniQ
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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Uni-Base AN, BioniQ, indexed, wide 08595573022730
Uni-Base AN, BioniQ, indexed, wide 08595573022709
Uni-Base AN, BioniQ, indexed, wide 08595573022778
Uni-Base AN, BioniQ, indexed, wide 08595573022723
Uni-Base AN, BioniQ, indexed, wide 08595573022747
Uni-Base AN, BioniQ, indexed, wide 08595573022754
Uni-Base AN, BioniQ, indexed, wide 08595573022761

Showing 12 of 71 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/uni-base-bioniq-indexed-wide-4643 · UDI page: /udi/08595573014643

All devices from LASAK s.r.o.

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