Skip to content

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 European Union

CE MDR

Valid until

16 Sep 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697529036M700HS Basic UDI-DI 06975290360988UDI-DIDate18 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

Germany
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Germany since 30 Sep 2026

Last checked 25 Oct 2026.

Specification

EUDAMED

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

  • Measuring Function

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