Polarmap™
by Boston Scientific Corporation United States EUDAMED
Ref M004CRBS7200
EMDN C02010499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number01915060000000000000217MT | Date24 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- G70 097167 0040 Cancelled
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 23 Mar 2023
- Expires
- 22 Mar 2028
- Reason
- Other
Specification
- Device Name
- POLARMAP Mapping Catheter
- Model / Reference
- M004CRBS7200
- Primary DI / UDI-DI
- 08714729992851
- Basic UDI-DI
- 01915060000000000000217MT
- EMDN Code
- C02010499 Arrhythmology multipolar diagnostic catheters – other
- Device Class
- Class III
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000004702
- Authorised representative
- Boston Scientific Limited IE-AR-000003840
Other devices from Boston Scientific
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- 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
Sources (1)
- EUDAMED 08714729992851|01915060000000000000217MT