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Tamas

by REMED Co., Ltd.

Ref 0171Model BrainStim, TAMAS, ALTMS

Tamas (0171) is a medical device (EU MDR Class IIb; EMDN category magnetic stimulators) made by REMED Co., Ltd., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI 8809308380195AF) with CE/MDR certificate 2025-MDR/QS-042 valid until 31 May 2028, active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8809308380195AF Basic UDI-DI 08809308380171UDI-DIDate9 Sep 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-042 Active

    Quality management system EU MDR

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

Timeline

3 dated events

  1. Certificate issued EUDAMED 2025-MDR/QS-042
  2. Registered EUDAMED 8809308380195AF
  3. Certificate expires EUDAMED 2025-MDR/QS-042

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Transcranial Magnetic Stimulator
Model / reference
BrainStim, TAMAS, ALTMS, 0171
Primary DI / UDI-DI
08809308380171
Basic UDI-DI
8809308380195AF
Direct marketing DI
08809308380171
EMDN code
Z12101105 Magnetic stimulators
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Romania

Manufacturer details

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

Similar devices in this category

Other devices filed under MAGNETIC STIMULATORS.

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See all devices from REMED Co., Ltd. →

Properties

Other properties (14, all answered No)