Hyaluxelle
by Ibsa Farmaceutici Italia SRL 5 variants
Ref 8053689863291
Expiring
CE MDR
Valid until
6 Jun 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number803363895ID0015E 08053689863291 | Date4 Sep 2026 | StatusActive |
Certificates
- EPT 0477.MDR.22/4993.2 Expiring
Technical documentation EU MDR
- Certifier
- Eurofins Product Testing Italy S.r.l. 0477
- Issued
- 19 Dec 2025
- Expires
- 6 Jun 2027
- EPT 0477.MDR.22/4994.2 Expiring
Quality management system EU MDR
- Certifier
- Eurofins Product Testing Italy S.r.l. 0477
- Issued
- 19 Dec 2025
- Expires
- 6 Jun 2027
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Device Name
- Hilow Hyaluronic Acid Sodium Salt for Vaginal Use
- Model / Reference
- 8053689863291
- Primary DI / UDI-DI
- 08053689863291
- Basic UDI-DI
- 803363895ID0015E
- Direct Marketing DI
- 08053689863291
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000008111
Other devices from IBSA Farmaceutici Italia Srl
Properties
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