Resonate™
by Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation United States EUDAMED
Ref G447
EMDN J01050301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number01915060000000000000083MW | Date29 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 32 countries, as listed in EUDAMED:
- Austriasince 22 Jul 2021
- Belgiumsince 22 Jul 2021
- Bulgariasince 22 Jul 2021
- Croatiasince 22 Jul 2021
- Cyprussince 22 Jul 2021
- Czechiasince 22 Jul 2021
- Denmarksince 22 Jul 2021
- Estoniasince 22 Jul 2021
- Finlandsince 22 Jul 2021
- Francesince 22 Jul 2021
- Germanysince 22 Jul 2021
- Greecesince 22 Jul 2021
- Hungarysince 22 Jul 2021
- Icelandsince 22 Jul 2021
- Irelandsince 22 Jul 2021
- Italysince 22 Jul 2021
- Latviasince 22 Jul 2021
- Liechtensteinsince 22 Jul 2021
- Lithuaniasince 22 Jul 2021
- Luxembourgsince 22 Jul 2021
- Maltasince 22 Jul 2021
- Netherlandssince 22 Jul 2021
- Northern Irelandsince 22 Jul 2021
- Norwaysince 22 Jul 2021
- Polandsince 22 Jul 2021
- Portugalsince 22 Jul 2021
- Romaniasince 22 Jul 2021
- Slovakiasince 22 Jul 2021
- Sloveniasince 22 Jul 2021
- Spainsince 22 Jul 2021
- Swedensince 22 Jul 2021
- Türkiyesince 22 Jul 2021
Certificates
- MDR 735821 Reissued
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 15 Jul 2026
- Expires
- 20 Jul 2031
- Valid from
- 20 Jul 2026
Specification
- Device Name
- Cardiac Resynchronization Therapy Defibrillator (CRT-D)
- Model / Reference
- G447
- Primary DI / UDI-DI
- 00802526589546
- Basic UDI-DI
- 01915060000000000000083MW
- EMDN Code
- J01050301 Implantable triple chamber defibrillators, with sensors
- Device Class
- Class III
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000010993
- Authorised representative
- Guidant Europe NV/SA; Boston Scientific BE-AR-000008410
Other devices from Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation
See all devices from Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation →
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 00802526589546|01915060000000000000083MW