Identity
- Trade Name
- Skinny EUDAMED
- Device Name
- Skinny PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- PS18-070040-070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720621317548 EUDAMED
- Basic UDI-DI
- 872062130004AH 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
Skinny 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 | 872062130004AH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cnovate Medical B.V.
- EUDAMED SRN
- NL-MF-000006042
Sources (1)
- EUDAMED d2f55092-12b5-488d-a84c-8b0b579d57c9 61 fields · synced Jun 18, 2026