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Europa Ultra CTO - Chronic Total Occlusion Coronary Balloon Catheter OTW 1.25mm…
EUDAMEDClass III (EU MDR)
Ref ΕΟ12/15Ref EO12/15Model Europa Ultra™ Family
Identity
- Trade Name
- Europa Ultra™ EUDAMED
- Device Name
- Europa Ultra CTO - Chronic Total Occlusion Coronary Balloon Catheter OTW 1.25mmx15mm EUDAMEDEuropa Ultra Coronary Balloon Catheter EUDAMED
- Model / Reference
- ΕΟ12/15 EUDAMEDEuropa Ultra™ Family EUDAMEDEO12/15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630033300612 EUDAMED
- Basic UDI-DI
- B-07630033300612 EUDAMED076300333EF_CBLCATHGG 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 CTO - Chronic Total Occlusion Coronary Balloon Catheter OTW 1.25mm… by Rontis Corporation SA — Class III — MDR, MDD — listed in EUDAMED
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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/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07630033300612 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-07630033300612 | 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 ff5b21d4-b11e-4266-b156-64a7704f3480 61 fields · synced Jul 11, 2026
- EUDAMED 1addad21-59af-42ce-9fc6-5c9447a81e22 61 fields · synced May 18, 2026