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Salus-Eswt-Expert

by REMED Co., Ltd.

Ref 09LModel SALUS-ESWT-EXPERT, SLAUS-FSWT, RSWT-A

Salus-Eswt-Expert (09L) is a Class IIa device made by REMED Co., Ltd., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 88093083803009L), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

31 May 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88093083803009L Basic UDI-DI 08809308380300UDI-DIDate23 Oct 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-059 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    22 Sep 2026
    Expires
    31 May 2028

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Shock Wave Therapy Equipment
Model / reference
SALUS-ESWT-EXPERT, SLAUS-FSWT, RSWT-A, 09L
Primary DI / UDI-DI
08809308380300
Basic UDI-DI
88093083803009L
Direct marketing DI
08809308380300
EMDN code
Z12139001 Shock wave therapy equipment
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000008128
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

Other properties (14, all answered No)