Wrist Electronic Blood Pressure Monitor
by Shenzhen Urion Technology Co., Ltd. 2 variants
Ref U62GHModel U62GH, U65H, U61GH, U60H, U61H, U62H, U63H, U67H, U68H, U60BH, U60K, U60B, U60CH, U60C, U60EH, U60E, U60I, U62I, U63I, U60GH, U60G
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 | Number69538259UWBP53 06953825911911 | Date16 May 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- Withdrawn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
- U62GH, U65H, U61GH, U60H, U61H, U62H, U63H, U67H, U68H, U60BH, U60K, U60B, U60CH, U60C, U60EH, U60E, U60I, U62I, U63I, U60GH, U60G
- Primary DI / UDI-DI
- 06953825911911
- Basic UDI-DI
- 69538259UWBP53
- Direct Marketing DI
- 06953825911911
- EMDN Code
- Z1203020501 Non–invasive oscillometric blood pressure gauges
- Device Class
- Class IIa
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000018740
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Shenzhen Urion Technology 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