One Touch
by Thai Nippon Rubber Industry Public Company Limited
Ref TNRTO001
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 | Number88529610TNRC01YQ 08852961025194 | Date27 Nov 2023 | 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- Withdrawn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
- Device Name
- Natural Rubber Latex Non-Medicated Male Condom
- Model / Reference
- TNRTO001
- Primary DI / UDI-DI
- 08852961025194
- Basic UDI-DI
- 88529610TNRC01YQ
- Direct Marketing DI
- 08852961025194
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TH-MF-000012641
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Thai Nippon Rubber Industry Public Company Limited
See all devices from Thai Nippon Rubber Industry Public Company Limited →
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