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OPTIMUS-Pro

by REMED Co., Ltd.

Ref 0188Model OPTIMUS-Pro

OPTIMUS-Pro (0188) is a Class IIa device made by REMED Co., Ltd., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 8809308380188AJ), 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 Number8809308380188AJ Basic UDI-DI 08809308380188UDI-DIDate23 Oct 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-060 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  • Withdrawn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
Electromagnetic Stimulator and Shock Wave Therapy Equipment
Model / reference
OPTIMUS-Pro, 0188
Primary DI / UDI-DI
08809308380188
Basic UDI-DI
8809308380188AJ
Direct marketing DI
08809308380188
EMDN code
Z120622, Z12139001
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Bulgaria

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)