69 Dotted
by Innolatex Sdn. Bhd. Malaysia EUDAMED
Ref P53D EMDN U110101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-09555163311001 | Date15 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- Non-sterile Non-medicated Natural Rubber Latex Male Condom
- Model / Reference
- P53D
- Primary DI / UDI-DI
- 09555163311001
- Basic UDI-DI
- B-09555163311001
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- Market of Registration
- Poland
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 (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED d709401a-e9ae-4e20-bd21-91f33bef7b64