Identity
- Trade Name
- Europa Ultra™ EUDAMED
- Device Name
- Europa Ultra Coronary Balloon Catheter EUDAMEDEuropa Ultra NC - Non-Compliant Coronary Balloon Catheter 2.0mmx20mm EUDAMED
- Model / Reference
- Europa Ultra™ Family EUDAMEDEN20/20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630033300681 EUDAMED
- Basic UDI-DI
- 076300333EF_CBLCATHGG EUDAMEDB-07630033300681 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Greece 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: Coronary angioplasty balloon catheter, cutting/scoring
Europa Ultra™ by Rontis Corporation SA — Class III — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 076300333EF_CBLCATHGG | Class III | Active |
| EUDAMED | European Union | CE/MDR | 076300333EF_CBLCATHGG | Class III | Active |
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Manufacturer
- Manufacturer
- Rontis Corporation SA
- EUDAMED SRN
- CH-MF-000031411
- Authorised Representative
- RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A. GR-AR-000023077
Sources (2)
- EUDAMED 5ef7cfbf-80ed-4673-b2c3-b31f716c4749 61 fields · synced Jul 8, 2026
- EUDAMED 120de4df-bc4d-491f-8b2c-98b2f6185ae1 61 fields · synced May 19, 2026