PREMENO Vaginalzäpfchen
by LO.LI. PHARMA S.r.l. Italy EUDAMED
Ref PREMENO VaginalzäpfchenModel Ovulo Vaginale / Vaginal Capsul EMDN U0899
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberEPT 0477.MDR.22/4914.2 | Date24 May 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- EPT 0477.MDR.22/4914.2 Reissued
Quality management system EU MDR
- Notified body
- Notified body 0477
- Issued
- 24 May 2024
- Expires
- 3 Aug 2027
Specification
- Device Name
- SANTES Ovuli
- Model / Reference
- Ovulo Vaginale / Vaginal Capsul, PREMENO Vaginalzäpfchen
- Primary DI / UDI-DI
- 08058481250799
- Basic UDI-DI
- 805848125SantesOvuliWF
- EMDN Code
- U0899 Gynaecological devices - other
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- IT-MF-000023734
Other devices from LO.LI. PHARMA S.r.l.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED b014aec3-2ed2-43c2-a70e-975e4a7819ae