Adrk
Ref ADRKModel ULTRASOUND SYSTEM SONIMAGE MX1
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 | Number4560141920000708E 04560141950115 | Date2 Jul 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- Withdrawn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
- Model / Reference
- ULTRASOUND SYSTEM SONIMAGE MX1, ADRK
- Primary DI / UDI-DI
- 04560141950115
- Basic UDI-DI
- 4560141920000708E
- Direct Marketing DI
- 04560141950115
- EMDN Code
- Z11040101 Internal ultrasound scanners
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- JP-MF-000008214
- Authorised representative
- Konica Minolta Business Solutions Europe GmbH NL-AR-000002026
Other devices from Konica Minolta, Inc.
Properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No