PROMED Automatic Upper Arm Blood Pressure Monitor
by Cofoe Medical Technology Co., Ltd. China EUDAMED
Ref KF-65DModel KF-65A、KF-65B、KF-65D、KF-65K、KF-65R
EMDN Z1203020501
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69507155BSXYJV2 | Date25 Feb 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Automatic Upper Arm Blood Pressure Monitor
- Model / Reference
- KF-65A、KF-65B、KF-65D、KF-65K、KF-65R, KF-65D
- Primary DI / UDI-DI
- 06950715573327
- Basic UDI-DI
- 69507155BSXYJV2
- EMDN Code
- Z1203020501 Non–invasive oscillometric blood pressure gauges
- Device Class
- Class IIa
- Market of Registration
- Germany
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 & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 6137d2ce-e3a1-4881-9fba-da972bf6a860