EndoTENS iOS app
by Sublimed
Ref END2AA200
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 | Number3770018808SBMTENSAPPNU B786END2AA2000 | Date23 Jun 2023 | 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- Withdrawn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
- Device Name
- actiTENS / actiTENS mini/ VitaliTENS / VitaliTENS mini
- Model / Reference
- END2AA200
- Primary DI / UDI-DI
- B786END2AA2000
- Basic UDI-DI
- 3770018808SBMTENSAPPNU
- Direct Marketing DI
- B786END2AA2000
- EMDN Code
- Z120601 Electrotherapy equipment (included tens)
- Device Class
- Class IIa
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000007546
Other devices from Sublimed
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