Unknown / Not in EUDAMED

Snapshot 2026-10-09 · Link to EUDAMED

Threadformer S3.5

UDI-DI 08595573021818Basic UDI-DI 85955730039YB

Class IIa · MDR · LASAK s.r.o.

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Identification

Model: Threadformer for guided surgery; Threadformer
EMDN: L159099
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: Yes

Certificates

2023-MDR/QS-039/A

EU quality management system · unknown

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

Valid from 2026-07-03 · 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

Threadformer for guided surgery S2.9 (GS) 08595573021764
Threadformer for guided surgery S3.5 (GS) 08595573021771
Threadformer for guided surgery S4.0/T4.0 (GS) 08595573021788
Threadformer for guided surgery S5.0/T5.0 (GS) 08595573021795
Threadformer S2.9 08595573021801
Threadformer S4.0/T4.0 08595573021825
Threadformer S5.0/T5.0 08595573021832

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/threadformer-s3-5-1818 · UDI page: /udi/08595573021818

All devices from LASAK s.r.o.

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