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Smart TMT

by REMED Co., Ltd.

Ref 0720Model Smart TMT

Smart TMT (0720) is a Class IIa device made by REMED Co., Ltd., registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 8809308380720AE) with CE/MDR certificate 2026-MDR/QS-043 valid until 31 May 2028, active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8809308380720AE Basic UDI-DI 08809308380720UDI-DIDate3 Sep 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2026-MDR/QS-043 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    29 Jun 2026
    Expires
    31 May 2028

Timeline

3 dated events

  1. Certificate issued EUDAMED 2026-MDR/QS-043
  2. Registered EUDAMED 8809308380720AE
  3. Certificate expires EUDAMED 2026-MDR/QS-043

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Radio Frequency Device
Model / reference
Smart TMT, 0720
Primary DI / UDI-DI
08809308380720
Basic UDI-DI
8809308380720AE
Direct marketing DI
08809308380720
EMDN code
Z12069099 Various physiotherapy and rehabilitation instruments - other
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)