Ipex, ABMG, ACTIMED, Quality Medical, Sky Medical, CMI
Ref BKT-PMModel Single, Double, Triple with/without sampling Device/sampling stopcock
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-8903283BKT-PMVX4R D-8903283BKT-PMVX4R | Date16 Oct 2026 | 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- Withdrawn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
- Device Name
- Pressure Monitoring Kit
- Model / Reference
- Single, Double, Triple with/without sampling Device/sampling stopcock, BKT-PM
- Primary DI / UDI-DI
- D-8903283BKT-PMVX4R
- Basic UDI-DI
- B-8903283BKT-PMVX4R
- EMDN Code
- Z12030102 Continuous positive pressure equipment
- Device Class
- Class IIb
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- IN-MF-000015362
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from B L Lifesciences Pvt. Ltd.
Properties
Other properties (10)
- 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