Mt-Smart
by Ami Inc.
Ref AMI-CL-0941Model MT-SMART
Mt-Smart (AMI-CL-0941) is a Class IIb device made by Ami Inc., registered in EUDAMED on 17 Jun 2024 (Basic UDI-DI B-08800042100278), active as of 7 Nov 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800042100278 08800042100278 | Date17 Jun 2024 | StatusActive |
Official records
- EUDAMED public site B-08800042100278
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Electrosurgical Unit and Sterile Disposable Electrode
- Model / reference
- MT-SMART, AMI-CL-0941
- Primary DI / UDI-DI
- 08800042100278
- Basic UDI-DI
- B-08800042100278
- EMDN code
- Z12010902 Electrosurgical units (esu) for general use
- Device class
- Class IIb
- System or procedure pack
- System which is a device in itself
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- KR-MF-000017522
- Authorised representative
- Obelis s.a. BE-AR-000000106
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