TENS/EMS Unit
by Shenzhen Aeon Technology Co., Ltd. China EUDAMED
Ref A621WModel A620, A621, A622, A620P, A621P, A622P, A620W, A621W, A622W
EMDN Z12062801
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69478325TMXX2024112700CK | Date17 Nov 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- A620, A621, A622, A620P, A621P, A622P, A620W, A621W, A622W
- Primary DI / UDI-DI
- 06947832500848
- Basic UDI-DI
- 69478325TMXX2024112700CK
- Direct Marketing DI
- 06947832500848
- EMDN Code
- Z12062801 Muscle reinforcement stimulators for innervated muscles
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000012690
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Aeon Technology Co., Ltd.
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 f71b673c-a07c-4d1d-9017-f99c4b120f59