Identity
- Trade Name
- RISE NC Non-Compliant PTCA Balloon Catheter EUDAMED
- Device Name
- RISE NC EUDAMEDRISE NC Non-Compliant PTCA Balloon Catheter EUDAMED
- Model / Reference
- NCB-35025 EUDAMEDNCB-20008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08888893025025 EUDAMED
- Basic UDI-DI
- B-08888893025025 EUDAMED8888893NCBSW EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Coronary angioplasty balloon catheter, cutting/scoring
Rise Nc by Biosensors Europe SA — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08888893025025 | Class III | Active |
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Manufacturer
- Manufacturer
- Biosensors Europe SA
- EUDAMED SRN
- CH-MF-000015764
- Authorised Representative
- NVT GmbH DE-AR-000006441
Sources (2)
- EUDAMED 3ed022b6-7d9e-4124-a231-6f34efb54418 61 fields · synced Oct 7, 2026
- EUDAMED 85ce3e5e-c961-4862-9c25-3d30e87c87ff 61 fields · synced Oct 7, 2026