Unisens
by Karex Industries Sdn. Bhd. 2 variants
Ref C1530DBEVF (Aloe Vera)
Active
CE MDD
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/MDD | NumberB-736211573216B8 | Date11 Sep 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Trade Name
- UnisensC1530DBEVF (Aloe Vera)
- Device Name
- Non-sterile Regular Plain Water-based Lubricant
- Model / Reference
- C1530DBEVF (Aloe Vera)
- Primary DI / UDI-DI
- D-736211573216B8, 09556564087946
- Basic UDI-DI
- B-736211573216B8, B-09556564087946
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class IIa
- EU market of registration
- SpainFrance
Manufacturer details
- EUDAMED SRN
- MY-MF-000001247
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Karex Industries Sdn. Bhd.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No