Ambulatory BP
by Suzhou Beneware Medical Equipment Co., Ltd. China EUDAMED
Ref ABP-021-ENModel ABP-021
EMDN Z1203020302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06958066406080 | Date21 Apr 2023 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Ambulatory blood pressure monitoring systems
- Model / Reference
- ABP-021, ABP-021-EN
- Primary DI / UDI-DI
- 06958066406080
- Basic UDI-DI
- B-06958066406080
- EMDN Code
- Z1203020302 Non–invasive blood pressure monitoring instruments
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000015853
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED e99878e4-e13b-4c64-8e39-5a3f1daa8094