Arm blood pressure monitor
by Shenzhen Combei Technology Co., Ltd. 6 variants
Ref BPCB0A-3HModel BP100A,BP101A,BP103A,BPCB0A-3H,BP163A,BP168A,BP122A,CUFF-A,CUFF-B,CUFF-C
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 | Number69481584ARM02T4 06948158400744 | Date28 Aug 2024 | 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- Withdrawn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
- Blood Pressure Monitor
- Model / Reference
- BP100A,BP101A,BP103A,BPCB0A-3H,BP163A,BP168A,BP122A,CUFF-A,CUFF-B,CUFF-C, BPCB0A-3H
- Primary DI / UDI-DI
- 06948158400744
- Basic UDI-DI
- 69481584ARM02T4
- Direct Marketing DI
- 06948158400744
- EMDN Code
- Z1203020501 Non–invasive oscillometric blood pressure gauges
- Device Class
- Class IIa
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000016047
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Shenzhen Combei 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