TENS/EMS Unit
by Shenzhen Aeon Technology Co., Ltd. 9 variants
Ref A622Model A620, A621, A622, A620P, A621P, A622P, A620W, A621W, A622W
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69478325TMXX2024112700CK 06947832500756 | Date17 Nov 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- A620, A621, A622, A620P, A621P, A622P, A620W, A621W, A622W
- Primary DI / UDI-DI
- 06947832500756
- Basic UDI-DI
- 69478325TMXX2024112700CK
- Direct Marketing DI
- 06947832500756
- EMDN Code
- Z12159085 Various pneumology and respiratory physiopathology instruments - consumables
- Device Class
- Class IIa
- EU market of registration
- Ireland
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
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