Natural rubber latex male condoms
by Fitone Latex Products Co., Ltd. Guangdong 3 variants
Ref COM002
Active
CE MDR
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/MDR | Number695937380004NQ | Date25 Mar 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- Natural rubber latex male condomsFITONE Natural rubber latex male condoms
- Model / Reference
- COM002
- Primary DI / UDI-DI
- 06959373819921, 06959373823966, 06959373823959, 06959373823874
- Basic UDI-DI
- 695937380004NQ
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000012805
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Fitone Latex Products Co., Ltd. Guangdong
See all devices from Fitone Latex Products Co., Ltd. Guangdong →
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