Automatic Upper Arm Blood Pressure Monitor
by Cofoe Medical Technology Co., Ltd. 4 variants
Ref KF-65B, KF0102Model KF-65A、KF-65B、KF-65D、KF-65K、KF-65R
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 | Number69507155BSXYJV2 06950715500163 | Date25 Feb 2025 | 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- Withdrawn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
- KF-65A、KF-65B、KF-65D、KF-65K、KF-65R, KF-65B, KF0102
- Primary DI / UDI-DI
- 06950715500163
- Basic UDI-DI
- 69507155BSXYJV2, B-06950715500163
- EMDN Code
- Z1203020501, V0399
- Device Class
- Class IIa
- EU market of registration
- SpainPoland
Manufacturer details
- EUDAMED SRN
- CN-MF-000001077
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Cofoe Medical 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