Identity
- Trade Name
- Zeeland EUDAMED
- Device Name
- Zeeland PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- PS14-030005-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720621342373 EUDAMED
- Basic UDI-DI
- 872062130003AF 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
Zeeland 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 | 872062130003AF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cnovate Medical B.V.
- EUDAMED SRN
- NL-MF-000006042
Sources (1)
- EUDAMED fb623ece-50b8-4a66-9540-8e2796b7e906 61 fields · synced Jun 18, 2026