Kysense Define
by Kylane Laboratoires EUDAMED
Active
Ref KYS-A110-4UModel Kysense
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number17649993074KYS4UJZ | Date8 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
EU market availability
Not listed: EUDAMED names no country where this device is made available.
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Kysense
- Model / Reference
- Kysense, KYS-A110-4U
- Primary DI / UDI-DI
- 07649993074297
- Basic UDI-DI
- 17649993074KYS4UJZ
- EMDN Code
- X0303 Substances, combinations of substances, or items without an intended medical purpose intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, by a prefilled means for introduction, excluding those for tattooing – resorbable
- Device Class
- Class III
- Medical Purpose
- The intended purpose of KYSENSE devices is to modify the facial anatomy and treat the facial aging for aesthetic purpose.
Manufacturer details
- EUDAMED SRN
- CH-PR-000032104