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UDI Compass
Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

StarFormer IntimaWave Chair

UDI-DI 03830054236592Basic UDI-DI 3830054230006SB

Class IIa · MDR · FOTONA, proizvodnja optoelektronskih naprav d.o.o.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

2022-MDR/QS-021/A

EU quality management system · valid

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

Valid from 2023-09-26 · Expiry 2027-09-21

Scope not stated in certificate data.

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

Manufacturer

FOTONA, proizvodnja optoelektronskih naprav d.o.o.

SRN SI-MF-000000126

SI · Ljubljana

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/starformer-intimawave-chair-6592 · UDI page: /udi/03830054236592

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