Identity
- Trade Name
- Europa Ultra™ EUDAMED
- Device Name
- Europa Ultra Coronary Balloon Catheter EUDAMEDEuropa Ultra CTO - Chronic Total Occlusion Coronary Balloon Catheter OTW 1.5mmx10mm EUDAMED
- Model / Reference
- Europa Ultra™ Family EUDAMEDEO15/10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630033300636 EUDAMED
- Basic UDI-DI
- 076300333EF_CBLCATHGG EUDAMEDB-07630033300636 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Romania 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 — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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- 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 | 076300333EF_CBLCATHGG | Class III | Active |
| EUDAMED | European Union | CE/MDD | 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 f4443ddf-522e-4177-a83c-6827cbd593f7 61 fields · synced Jul 17, 2026
- EUDAMED 8a33444a-dc4a-4596-aeba-8c7b6ba40477 61 fields · synced May 16, 2026