KMScreen DICOM PC
by Ortho Km Sweden EUDAMED
Ref KMScreen DICOM PCModel KMScreen SDL FULL
EMDN Z1212012004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7350115200431S2 | Date4 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- KMScreen SDL FULL
- Model / Reference
- KMScreen SDL FULL, KMScreen DICOM PC
- Primary DI / UDI-DI
- 73501152026642
- Basic UDI-DI
- 7350115200431S2
- Direct Marketing DI
- 73501152026642
- EMDN Code
- Z1212012004 Hess screens
- Device Class
- Class I
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000044308
Other devices from Ortho Km
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 6f5e4b3e-b51c-45e3-9ad1-424715d9d205