Emblem™
by Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation 4 variants
Ref 3501
Active
CE MDR
Valid until
24 May 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 743490 | Date18 May 2026 | StatusActive |
Certificates
- MDR 743490 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 18 May 2026
- Expires
- 24 May 2031
- Valid from
- 24 May 2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- S-ICD Subcutaneous Electrode
- Model / Reference
- 3501
- Primary DI / UDI-DI
- 00802526586804
- Basic UDI-DI
- 01915060000000000000004M8
- EMDN Code
- J019001020101 Permanent cardiac defibrillator leads, single coil
- Device Class
- Class III
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 (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No