Altms
Ref 0607Model BrainStim, TAMAS, ALTMS
Altms (0607) 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 25 Oct 2026.
Active
CE MDR
Valid until
31 May 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8809308380195AF 08809308380607 | Date9 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 8809308380195AF
Certificates
- 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
- Certificate issued EUDAMED 2025-MDR/QS-042
- Registered EUDAMED 8809308380195AF
- Certificate expires EUDAMED 2025-MDR/QS-042
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Transcranial Magnetic Stimulator
- Model / reference
- BrainStim, TAMAS, ALTMS, 0607
- Primary DI / UDI-DI
- 08809308380607
- Basic UDI-DI
- 8809308380195AF
- Direct marketing DI
- 08809308380607
- 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
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