Patient monitor
Ref UM2017, VS2000C, PM6800, UM2012, iPM800, PM6000Model VS2000、PM5000、PM6000、PM6800、UM2012、UM2017
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 | Number697424710PmonitorsAK | Date13 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- Withdrawn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
- Model / Reference
- VS2000、PM5000、PM6000、PM6800、UM2012、UM2017, UM2017, VS2000C, PM6800, UM2012, iPM800, PM6000
- Primary DI / UDI-DI
- 06974247100158, 06974247100080, 06974247100134, 06974247100141, 06974247100103, 06974247100127
- Basic UDI-DI
- 697424710PmonitorsAK
- Direct Marketing DI
- 069742471001580697424710008006974247100134069742471001410697424710010306974247100127
- EMDN Code
- Z1203020202 Transportable/portable multi–parameter patient monitors
- Device Class
- Class IIb
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000002142
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from UTECH Co., Ltd.
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