Fair Square Ultimate Thin
by Karex Industries Sdn. Bhd. 2 variants
Ref P53S FXST
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-04260663812501 | Date3 Aug 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Non-sterile Non-medicated Natural Rubber Latex Male Condom
- Model / Reference
- P53S FXST
- Primary DI / UDI-DI
- 04260663812501, 04260663812532
- Basic UDI-DI
- B-04260663812501, B-04260663812532
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- MY-MF-000001247
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Karex Industries Sdn. Bhd.
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No