Automated External Defibrillator
by ViVest Medical Technology Co., Ltd.
Ref PowerBeat X3
Active
CE MDD
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/MDD | NumberB-06973107240089 06973107240089 | Date27 Oct 2021 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- PowerBeat X3
- Primary DI / UDI-DI
- 06973107240089
- Basic UDI-DI
- B-06973107240089
- EMDN Code
- Z12030503 Automatic defibrillators
- Device Class
- Class IIb
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000015304
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from ViVest Medical Technology Co., Ltd.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No