Immunovag (35 ml tube + 5 single-use vaginal applicators)
Ref 1DEP01400Model 1 tube of 35 ml + 5 single-use vaginal applicators; Free sample – not for sale (35 ml tube filled with 10 ml + 1 single-use vaginal applicator)
Active
CE MDR
Valid until
16 Nov 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 000128-A | Date16 Jul 2026 | StatusActive |
Certificates
- MDR 000128-A Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 16 Jul 2026
- Expires
- 16 Nov 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Gel-based medical devices for the protection of the vaginal mucosa in the presence of bacterial and fungal infections
- Model / Reference
- 1 tube of 35 ml + 5 single-use vaginal applicators, Free sample – not for sale (35 ml tube filled with 10 ml + 1 single-use vaginal applicator), 1DEP01400
- Primary DI / UDI-DI
- 08050046270020
- Basic UDI-DI
- 805004627DEPOFARMA014003Q
- EMDN Code
- U0803 Vaginal devices in the form of solutions/creams/ova/tablets
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000027122
Other devices from Depofarma S.P.A.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- 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