EUDAMED device
MyONE® Custom Fit™
EUDAMED device 00276893117273 · Karex Industries Sdn. Bhd.
Key facts
| Primary DI | 00276893117273 |
|---|---|
| Trade name | MyONE® Custom Fit™ |
| Device name | Non-sterile, Non-medicated Natural Rubber Latex Male Condoms |
| Reference or catalog number | MY-53E-312 |
| Manufacturer | Karex Industries Sdn. Bhd. |
| Manufacturer SRN | MY-MF-000001247 |
| Risk class | Class IIb |
| EMDN code | U110101 |
| EMDN description | CONDOMS |
| Legislation | mdr |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | Jan 19, 2026 |
At a glance
- No Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: