Foledrain™
by Mais India Medical Devices Pvt. Ltd. EUDAMED
Active
Ref MI/CA/01-000-EModel Foley Balloon Catheter - Latex/Silicon (2 Way/3 Way)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number890606548U03NS | Date12 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Foley Balloon Catheter
- Model / Reference
- Foley Balloon Catheter - Latex/Silicon (2 Way/3 Way), MI/CA/01-000-E
- Primary DI / UDI-DI
- 08906065483890, 08906065483852, 08906065483814, 08906065483838, 08906065483883, 08906065483845, 08906065483791, 08906065483913
- Basic UDI-DI
- 890606548U03NS
- Direct Marketing DI
- 0890606548389008906065483852089060654838140890606548383808906065483883089060654838450890606548379108906065483913
- EMDN Code
- U0199,U020199
- Device Class
- Class IIa
- Market of Registration
- BulgariaIrelandCzechiaFranceIcelandCroatiaDenmark
Manufacturer details
- EUDAMED SRN
- IN-MF-000021842
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Mais India Medical Devices Pvt. Ltd.
Properties
Other properties (11)
- Implantable: No
- Reusable: 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