LUX-Dx™
by Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation 3 variants
Ref M301
Expiring
CE MDR
Valid until
23 Aug 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 749618 | Date18 Sep 2026 | StatusExpiring |
Certificates
- MDR 749618 Expiring
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 18 Sep 2026
- Expires
- 23 Aug 2027
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Device Name
- Insertable cardiac monitor (ICM) sensor
- Model / Reference
- M301
- Primary DI / UDI-DI
- 00802526607110
- Basic UDI-DI
- 01915060000000000000219MX
- EMDN Code
- J010201 Implantable diagnostic arrhythmias recording cardiac devices
- Device Class
- Class III
- EU 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
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