NeuroSpeed PTA Balloon Catheter
by Acandis GmbH Germany EUDAMED
Ref 01-000614 EMDN C010499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426065033NeuroSpeedNR | Date14 May 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 1000269464 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 30 Oct 2025
- Expires
- 31 Aug 2028
- Reason
- Change approved
- 1000331236 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 6 Aug 2026
- Expires
- 22 Mar 2028
- Reason
- Change approved
Specification
- Model / Reference
- 01-000614
- Primary DI / UDI-DI
- 04260697380854
- Basic UDI-DI
- 426065033NeuroSpeedNR
- Direct Marketing DI
- 04260697380854
- EMDN Code
- C010499 Angiography and hemodynamics devices - other
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006259
Other devices from Acandis GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- 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 04260697380854|426065033NEUROSPEEDNR