INNO Dotted
by Innolatex Sdn. Bhd. Malaysia EUDAMED
Ref GR03-003
EMDN U110101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955516330-NMCM-6F | Date28 Oct 2025 | StatusWithdrawn |
Coverage
- Withdrawn
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Device Name
- Non-sterile Non-medicated Natural Rubber Latex Male Condoms
- Model / Reference
- GR03-003
- Primary DI / UDI-DI
- 09555163311506
- Basic UDI-DI
- 955516330-NMCM-6F
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
Manufacturer details
- EUDAMED SRN
- MY-MF-000001246
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Innolatex Sdn. Bhd.
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 (1)
- EUDAMED 02a7caba-6c6a-4701-ba15-393252fcd021