FMS Stym
by Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike Slovenia EUDAMED
Ref MS001Model 31 Models from MDR Certificate 2023-MDR/QS-009/D
EMDN Z120606
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2023-MDR/QS-009/D | Date15 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2023-MDR/QS-009/D Reissued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 15 May 2026
- Expires
- 15 May 2031
Specification
- Device Name
- Medical devices for Magneto Therapy
- Model / Reference
- 31 Models from MDR Certificate 2023-MDR/QS-009/D, MS001
- Primary DI / UDI-DI
- 03830066951902
- Basic UDI-DI
- 383006695FMSJ5
- Direct Marketing DI
- 03830066951902
- EMDN Code
- Z120606 Magnetotherapy equipment
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- SI-MF-000006345
Other devices from Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 18e4a6ce-1c12-4f76-899b-834970884d88