Fair Squared Ultra Thin
by Innolatex (Thailand) Limited EUDAMED
Active
Ref P53S-FXUT, 4719647
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-04260365853123 | Date29 Oct 2024 | StatusActive |
| European Union | CE/MDD | NumberB-04260365853123 | Date29 Oct 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Non-medicated Natural Rubber Latex Male Condoms.Non-sterile, Non-medicated Natural Rubber Latex Male Condoms
- Model / Reference
- P53S-FXUT, 4719647
- Primary DI / UDI-DI
- 04260365853123
- Basic UDI-DI
- B-04260365853123, 9556564-NMCM-U4
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- Market of Registration
- GermanyAustria
Manufacturer details
- EUDAMED SRN
- TH-MF-000001249
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Innolatex (Thailand) Limited
Properties
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