Defibrillator/Monitor
by Primedic(Jiangsu) Medical Technology Co., Ltd .
Ref Defibrillator/MonitorModel DefiMonitor XD51 Pro,DefiMonitor XD75Plus,DefiMonitor XD75Pro,DefiMonitor XD700,DefiMonitor XD70,DefiMonitor XD7000,DefiMonitor XD76Lite,DefiMonitor XD61 Pro,DefiMonitor XD7Pro,DefiMonitor XD700Pro,DefiMonitor XD7000Pro,DefiMonitor XD70Pro
Active
CE MDR
Valid until
16 Sep 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697529036M700HS 06975290360988 | Date18 Sep 2026 | StatusActive |
Certificates
- G70 119016 0010 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 17 Sep 2026
- Expires
- 16 Sep 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
EU market availability
Made available in 1 country, as listed in EUDAMED:
- Germany since 30 Sep 2026
Specification
- Device Name
- Defibrillator/Monitor
- Model / Reference
- DefiMonitor XD51 Pro, DefiMonitor XD75Plus, DefiMonitor XD75Pro, DefiMonitor XD700, DefiMonitor XD70, DefiMonitor XD7000, DefiMonitor XD76Lite, DefiMonitor XD61 Pro, DefiMonitor XD7Pro,DefiMonitor XD700Pro,DefiMonitor XD7000Pro, DefiMonitor XD70Pro, Defibrillator/Monitor
- Primary DI / UDI-DI
- 06975290360988
- Basic UDI-DI
- 697529036M700HS
- EMDN Code
- Z12030501 Semi-automatic defibrillators
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000045540
- Authorised representative
- Metrax GmbH DE-AR-000005481
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