Transducer for Diagnostic Ultrasound System
Ref PLU-705BTHModel PSI-28VX, PET-835LA, PVU-475BT, etc.
Active
CE MDR
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/MDR | Number4987670A0402RH 04987670103773 | Date18 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Transducer for Diagnostic Ultrasound System
- Model / Reference
- PSI-28VX, PET-835LA, PVU-475BT, etc., PLU-705BTH
- Primary DI / UDI-DI
- 04987670103773
- Basic UDI-DI
- 4987670A0402RH
- EMDN Code
- Z110402010101 Two–dimensional linear–array transcutaneous ultrasound probes
- Device Class
- Class IIa
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- JP-MF-000013254
- Authorised representative
- Canon Medical Systems Europe B.V. NL-AR-000010531
Other devices from Canon Inc.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: 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