2cm Peripheral Cutting Balloon™
by Boston Scientific Corporation United States EUDAMED
Ref M001BP90520B0 EMDN C010402020199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-08714729408321 | Date13 Oct 2026 | StatusActive |
| European Union | CE/MDD | NumberB-08714729408321 | Date13 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- 2cm Peripheral Cutting BalloonTM Microsurgical Dilatation Device2cm Peripheral Cutting Balloon
- Model / Reference
- M001BP90520B0
- Primary DI / UDI-DI
- 08714729408321
- Basic UDI-DI
- B-08714729408321, 01915060000000000000507N7
- EMDN Code
- C010402020199 PTA dilatation catheters - other
- Device Class
- Class IIa
- 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 (2)
- EUDAMED 08714729408321|B-08714729408321
- EUDAMED 08714729408321|01915060000000000000507N7