Manix
by Suretex Limited Thailand EUDAMED
Ref 300390, 300470, 300392, 300394Model Manix Contact Plus, NRL condoms non medicated lubricant, MANIX CONTACT PLUS
EMDN U110101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-03532281684404 | Date3 Nov 2021 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Manix Contact Plus 6Manix Contact Plus 12+2Manix Contact Plus 24
- Model / Reference
- Manix Contact Plus, 300390, NRL condoms non medicated lubricant, 300470, 300392, 300394
- Primary DI / UDI-DI
- 03532281684404, 03532281403401, 03532281684626, 03532281684800
- Basic UDI-DI
- B-03532281684404, 5011831NRLcondom-NMLubY2, B-03532281684626, B-03532281684800
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- TH-MF-000001364
- Authorised representative
- SXWell Belgium BE-AR-000001272
Other devices from Suretex Limited
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- 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
Sources (4)
- EUDAMED b96f9cd9-ecb7-495e-b382-cd06947d3cf6
- EUDAMED 03532281403401|5011831NRLCONDOM-NMLUBY2
- EUDAMED 03532281684626|B-03532281684626
- EUDAMED 03532281684800|B-03532281684800