Lafullen
by Samyang Biopharm Corporation South Korea EUDAMED
Ref DMFI300DModel DMFI300, DMFI300D
EMDN X0303
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880976632FI01LU | Date30 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2026-AXVI/TD-003/A Supplemented
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 28 Sep 2026
- Expires
- 12 Dec 2029
- Reason
- Other
- 2026-AXVI/QS-003/A Supplemented
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 28 Sep 2026
- Expires
- 12 Dec 2026
- Reason
- Other
Specification
- Device Name
- PCL(Polycaprolactone) Based Dermal Filler
- Model / Reference
- DMFI300, DMFI300D
- Primary DI / UDI-DI
- 08809961546693
- Basic UDI-DI
- 880976632FI01LU
- 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
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- KR-MF-000037085
- Authorised representative
- Samyang Biopharm Magyarország Kft. HU-AR-000035346
Other devices from Samyang Biopharm Corporation
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- 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 08809961546693|880976632FI01LU