Identity
- Trade Name
- Rialto EUDAMED
- Device Name
- Rialto NC PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- PN14-080060-070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720621323969 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
Rialto by Cnovate Medical B.V. — Class IIa — 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 | 872062130006AM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cnovate Medical B.V.
- EUDAMED SRN
- NL-MF-000006042
Sources (1)
- EUDAMED 27b2557d-ea66-48ac-9405-615208366c62 61 fields · synced Jun 18, 2026