Fair Squared Intense
by Karex Industries Sdn. Bhd. Malaysia EUDAMED
Ref 4910659
EMDN U110101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9556564-NMCM-U4 | Date19 Dec 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Non-sterile, Non-medicated Natural Rubber Latex Male Condoms
- Model / Reference
- 4910659
- Primary DI / UDI-DI
- 04262358580290
- Basic UDI-DI
- 9556564-NMCM-U4
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- MY-MF-000001247
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Karex Industries Sdn. Bhd.
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 (1)
- EUDAMED e2be5b68-bb20-4034-9c43-7c28009f9755