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Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

FSWT-A

UDI-DI 08809308380836Basic UDI-DI 88093083803009L

Class IIa · MDR · REMED Co.,Ltd.

Identification
Model
SALUS-ESWT-EXPERT, SLAUS-FSWT, RSWT-A
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

2026-MDR/QS-059

EU quality management system · valid

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

Valid from 2026-09-22 · Expiry 2028-05-31

Scope not stated in certificate data.

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

Manufacturer

REMED Co.,Ltd.

SRN KR-MF-000008128

KR · Cheongju-si, Chungcheongbuk-do

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/fswt-a-0836 · UDI page: /udi/08809308380836

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