← Back to catalogue
Europa Ultra - Semi-Compliant Coronary Balloon Catheter 2.0mmx20mm
EUDAMEDClass III (EU MDR)
Ref EL20/20Model Europa Ultra™ Family
Identity
- Trade Name
- Europa Ultra™ EUDAMED
- Device Name
- Europa Ultra - Semi-Compliant Coronary Balloon Catheter 2.0mmx20mm EUDAMEDEuropa Ultra Coronary Balloon Catheter EUDAMED
- Model / Reference
- EL20/20 EUDAMEDEuropa Ultra™ Family EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630033300032 EUDAMED
- Basic UDI-DI
- B-07630033300032 EUDAMED076300333EF_CBLCATHGG 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 - Semi-Compliant Coronary Balloon Catheter 2.0mmx20mm by Rontis Corporation SA — Class III — MDR, MDD — listed in EUDAMED
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- Kulani™ NC — Meril Life Sciences Pvt. Ltd. · Class III
- Invader PTCA — Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. · Class III
- Wolverine Coronary Cutting Balloon — Boston Scientific · Class III
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07630033300032 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-07630033300032 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
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 d8b86ed9-0c9d-4b4b-8864-d38a640ccc2a 61 fields · synced Jun 19, 2026
- EUDAMED 5d9768d1-b9da-4e4a-9584-2d3f780828ce 61 fields · synced May 19, 2026