COOP Classic
by Thai Nippon Rubber Industry Public Company Limited
Ref FIPSWZ-001
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 08852961028461 | 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- Withdrawn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
- FIPSWZ-001
- Primary DI / UDI-DI
- 08852961028461
- Basic UDI-DI
- 88529610TNRC01YQ
- Direct Marketing DI
- 08852961028461
- 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
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Properties
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