Blood pressure monitor
by Wenzhou Bokang Instruments Co., Ltd
Ref BK6052Model BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032
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 | Number69310386ELC001C7 06931038660529 | Date6 May 2023 | 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- Withdrawn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
- Electronic sphygmomanometer
- Model / Reference
- BK1016, BK1018, BK1016B, BK1016T, BK6002, BK6022, BK6032, BK6052
- Primary DI / UDI-DI
- 06931038660529
- Basic UDI-DI
- 69310386ELC001C7
- EMDN Code
- C9006 Aneroid sphygmomanometers
- Device Class
- Class IIa
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- CN-MF-000021505
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Wenzhou Bokang Instruments 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