High Intensity Focused Ultrasonic Equipment
by Daeju Meditech Engineering Co., Ltd EUDAMED
Active
Ref DJMD0001Model HIPRO
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800017500089 | Date16 Jun 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- High Intensity Focused Ultrasound System
- Model / Reference
- HIPRO, DJMD0001
- Primary DI / UDI-DI
- 08800017500089
- Basic UDI-DI
- B-08800017500089
- EMDN Code
- Z120610 Ultrasound therapy equipment
- Device Class
- Class IIa
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- KR-MF-000020683
- Authorised representative
- Javitech Consulting GmbH DE-AR-000045915
Other devices from Daeju Meditech Engineering Co., Ltd
Properties
Other properties (10)
- Sterile: No
- Implantable: 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