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Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

Ratchet BioniQ

UDI-DI 08595573019655Basic UDI-DI 85955730006XU

Class Im · MDR · LASAK s.r.o.

Identification
Model
Ratchet BioniQ
EMDN
V0399
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
Yes
Reusable surgical
Yes
Certificates

2023-MDR/QS-040

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

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ratchet-bioniq-9655 · UDI page: /udi/08595573019655

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