Juveselle
Ref VolumeModel Fine, Classic, Volume
Active
CE MDR
Valid until
9 Jan 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2026-AXVI/QS-002/A | Date6 Oct 2026 | StatusActive |
Certificates
- 2026-AXVI/QS-002/A Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 6 Oct 2026
- Expires
- 9 Jan 2028
- Reason
- Other
- 2026-AXVI/TD-002/A Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 6 Oct 2026
- Expires
- 9 Jan 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Cross-linked Hyaluronic Acid Dermal Filler with Polynucleotide
- Model / Reference
- Fine, Classic, Volume
- Primary DI / UDI-DI
- 08809369096967
- Basic UDI-DI
- 880936909BNC004HE
- 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
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000008321
- Authorised representative
- Javitech Consulting GmbH DE-AR-000045915
Other devices from BNC KOREA, Inc.
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No