Digital Radiography X-ray System
Ref JSA-Brochure-01Model Clear Vision DRE140/150
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 | Number880941381DRE140/1505D 08809413811188 | Date29 Apr 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- Withdrawn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
- Digital Radiography X-ray System
- Model / Reference
- Clear Vision DRE140/150, JSA-Brochure-01
- Primary DI / UDI-DI
- 08809413811188
- Basic UDI-DI
- 880941381DRE140/1505D
- EMDN Code
- Z11031101 Multifunctional systems for direct digital radiology
- Device Class
- Class IIb
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- KR-MF-000002016
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Jpi Healthcare. Co., Ltd.
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