Identity
- Trade Name
- Vela RX EUDAMED
- Device Name
- Vela RX PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 23030140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970226523345 EUDAMED
- Basic UDI-DI
- 697022652105FN EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Estonia 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
Vela RX by Curatia Medical Limited — 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 | 697022652105FN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Curatia Medical Limited
- EUDAMED SRN
- CN-MF-000015976
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (1)
- EUDAMED 0b82bdfd-fa03-46f1-8485-8c59193a28f3 61 fields · synced Jun 19, 2026