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ZTone

by REMED Co., Ltd.

Ref 0492Model ZTone

ZTone (0492) is a medical device (EU MDR Class IIa; EMDN category muscle stimulators) made by REMED Co., Ltd., registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 8809308380492AQ) with CE/MDR certificate 2023-MDR/QS-008/B 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 Number8809308380492AQ Basic UDI-DI 08809308380492UDI-DIDate3 Sep 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2023-MDR/QS-008/B Active Amended

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    12 Aug 2025
    Expires
    31 May 2028
    Reason
    Mnf data change

Timeline

3 dated events

  1. Certificate issued EUDAMED 2023-MDR/QS-008/B
  2. Registered EUDAMED 8809308380492AQ
  3. Certificate expires EUDAMED 2023-MDR/QS-008/B

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Electromagnetic Stimulator
Model / reference
ZTone, 0492
Primary DI / UDI-DI
08809308380492
Basic UDI-DI
8809308380492AQ
Direct marketing DI
08809308380492
EMDN code
Z120622 Muscle stimulators
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

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

Similar devices in this category

Other devices filed under MUSCLE STIMULATORS.

Other devices from REMED Co., Ltd.

See all devices from REMED Co., Ltd. →

Properties

Other properties (14, all answered No)