Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

T CARE

UDI-DI 03830066951964Basic UDI-DI 383006695FMSJ5

Class IIa · MDR · Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike

Scan an inventory CSV

Identification

Model: 31 Models from MDR Certificate 2023-MDR/QS-009/D
EMDN: Z120606
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

2023-MDR/QS-009/D

EU quality management system · valid

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

Valid from 2026-05-15 · Expiry 2031-05-15

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike

SRN SI-MF-000006345

SI · Ljubljana

manufacturer

Related UDI-DIs

FMS 4 03830066952015
FMS Care 03830066951933
FMS CARE BF 03830066951971
FMS Care II 03830066952176
FMS Care prestige 03830066951940
FMS Duo 03830066951957
FMS Former 03830066951995
FMS Former prestige 03830066952008
FMS Gym 03830066952107
FMS Precision 03830066952206
FMS Quattro 03830066952022
FMS Stym 03830066951902

Showing 12 of 30 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/t-care-1964 · UDI page: /udi/03830066951964

All devices from Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike

Scan an inventory CSV