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RISE SC Semi-Compliant PTCA Balloon Catheter
EUDAMEDClass III (EU MDR)
Ref RSC-30030Model RSC-10008
Identity
- Trade Name
- RISE SC Semi-Compliant PTCA Balloon Catheter EUDAMED
- Device Name
- RISE SC Semi-Compliant PTCA Balloon Catheter EUDAMED
- Model / Reference
- RSC-10008 EUDAMEDRSC-30030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08888893031262 EUDAMED
- Basic UDI-DI
- 8888893RSCV4 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 SC Semi-Compliant PTCA Balloon Catheter 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 | 8888893RSCV4 | 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 (1)
- EUDAMED 417ea00b-118a-4fd4-9137-b868de8995ce 61 fields · synced Oct 7, 2026