Estyme Form
Ref FORM1-300
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 | Number376017216PPFASYFLY 03760172160601 | Date9 Jul 2026 | 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- Withdrawn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
- FORM1-300
- Primary DI / UDI-DI
- 03760172160601
- Basic UDI-DI
- 376017216PPFASYFLY
- 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
- ESTYME FORM is indicated to correct nasolabial folds. ESTYME FORM is injected into the dermis to hypodermis.
Manufacturer details
- EUDAMED SRN
- FR-PR-000033604