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-22510 EUDAMEDNCB-20008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08888893024684 EUDAMED
- Basic UDI-DI
- B-08888893024684 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
Rise Nc by Biosensors Europe SA — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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-08888893024684 | 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 dc523e46-19c4-4cc4-9285-8cb289f358cd 61 fields · synced Oct 8, 2026
- EUDAMED b91ef6d4-a650-415e-b82e-b2029a4a73b6 61 fields · synced Oct 8, 2026