Biguanelle Gel
by LO.LI. PHARMA S.r.l. Italy EUDAMED
Ref BIGUANELLE GELModel MONOGIN GEL EMDN U0899
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805848125MONOGINgelZ9 | Date29 Jan 2024 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Withdrawn
Certificates
- EPT 0477.MDR.23/5054.1 Reissued
Quality management system EU MDR
- Notified body
- Notified body 0477
- Issued
- 6 Feb 2023
- Expires
- 3 Aug 2027
Specification
- Device Name
- Monogin Gel
- Model / Reference
- MONOGIN GEL, BIGUANELLE GEL
- Primary DI / UDI-DI
- 08058481250461, 08058481250454, 08058481250447, 08058481250423, 08058481250430
- Basic UDI-DI
- 805848125MONOGINgelZ9
- EMDN Code
- U0899 Gynaecological devices - other
- Device Class
- Class IIb
- Market of Registration
- BulgariaGermany
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 (5)
- EUDAMED b196b294-3cf9-414a-9cbc-c6bb457b7ecb
- EUDAMED 08058481250454|805848125MONOGINGELZ9
- EUDAMED 08058481250447|805848125MONOGINGELZ9
- EUDAMED 08058481250423|805848125MONOGINGELZ9
- EUDAMED 08058481250430|805848125MONOGINGELZ9