Biguanelle
by LO.LI. PHARMA S.r.l. Italy EUDAMED
Ref BIGUANELLE EMDN U0899
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberEPT 0477.MDR.23/5060.3 | Date19 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- EPT 0477.MDR.23/5060.3 Reissued
Quality management system EU MDR
- Notified body
- Notified body 0477
- Issued
- 19 Dec 2025
- Expires
- 3 Aug 2027
Specification
- Device Name
- Monogin Soluzione
- Model / Reference
- BIGUANELLE
- Primary DI / UDI-DI
- 08058481250867, 08058481250157, 08058481250911, 08058481251291
- Basic UDI-DI
- 805848125MONOGINsoluzNX
- EMDN Code
- U0899 Gynaecological devices - other
- Device Class
- Class IIb
- Market of Registration
- CroatiaGermanyCyprus
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 (4)
- EUDAMED 57311b81-2a2f-47a5-894d-d317efc1a640
- EUDAMED 08058481250157|805848125MONOGINSOLUZNX
- EUDAMED 08058481250911|805848125MONOGINSOLUZNX
- EUDAMED 08058481251291|805848125MONOGINSOLUZNX