Inno Regular
by Innolatex Sdn. Bhd. Malaysia EUDAMED
Ref P53S, LT01-003, LT01-002 EMDN U110101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-09555163311155 | Date15 Aug 2023 | StatusActive |
| European Union | CE/MDD | NumberB-09555163311155 | Date15 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- Inno RegularInno Smooth
- Device Name
- Non-sterile Non-medicated Natural Rubber Latex Male CondomNon-sterile Non-medicated Natural Rubber Latex Male Condoms
- Model / Reference
- P53S, LT01-003, LT01-002
- Primary DI / UDI-DI
- 09555163311155, 09555163311124
- Basic UDI-DI
- B-09555163311155, B-09555163311124, 955516330-NMCM-6F
- EMDN Code
- U110101 Condoms
- Device Class
- Class IIb
- Market of Registration
- BulgariaGreece
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 (4)
- EUDAMED 2775cc5f-33bf-4517-856c-ea296e466640
- EUDAMED 09555163311124|B-09555163311124
- EUDAMED 09555163311155|955516330-NMCM-6F
- EUDAMED 09555163311124|955516330-NMCM-6F