Sensitive 6
by Sagami Manufacturers Sdn. Bhd. Malaysia EUDAMED
Ref UES332
EMDN U110101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number4974234PUCDM015U | Date30 Jan 2024 | StatusActive |
| European Union | CE/MDR | Number4974234PUCDM015U | Date30 Jan 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Trade Name
- Sensitive 6Sensitive
- Device Name
- Polyurethane Condom
- Model / Reference
- UES332
- Primary DI / UDI-DI
- 07310576900073
- Basic UDI-DI
- 4974234PUCDM015U, B-07310576900073
- Direct Marketing DI
- 07310576900073
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- MY-MF-000039689
- Authorised representative
- Sagami Europe SAS FR-AR-000038926
Other devices from Sagami Manufacturers Sdn. Bhd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: 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 d91d9dba-1abb-46e1-8ca3-e156ff20f19a
- EUDAMED f0c79f2f-11a1-46aa-8046-4071b03fa6d3