Identity
- Trade Name
- Rialto EUDAMED
- Device Name
- Rialto NC PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- PN14-055100-090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720621324713 EUDAMED
- Basic UDI-DI
- 872062130006AM EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa 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: Peripheral angioplasty balloon catheter, basic
Rialto by Cnovate Medical B.V. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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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 | 872062130006AM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cnovate Medical B.V.
- EUDAMED SRN
- NL-MF-000006042
Sources (1)
- EUDAMED e087730b-ee26-414c-b5cc-147ac6b55180 61 fields · synced Jun 18, 2026