Natural rubber latex male condoms
by Fitone Latex Products Co., Ltd. Guangdong China EUDAMED
Ref COM002
EMDN U110101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number695937380004NQ | Date25 Mar 2025 | StatusActive |
Coverage
- Active
- 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
- 06959373823942, 06959373823904
- Basic UDI-DI
- 695937380004NQ
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000012805
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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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 (2)
- EUDAMED 58b45585-6407-4074-b80c-9fcdfc4e4f18
- EUDAMED 06959373823904|695937380004NQ