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Europa Ultra NC - Non-Compliant Coronary Balloon Catheter 2.25mmx15mm
EUDAMEDClass III (EU MDR)
Ref EN22/15Model Europa Ultra™ Family
Identity
- Trade Name
- Europa Ultra™ EUDAMED
- Device Name
- Europa Ultra NC - Non-Compliant Coronary Balloon Catheter 2.25mmx15mm EUDAMEDEuropa Ultra Coronary Balloon Catheter EUDAMED
- Model / Reference
- EN22/15 EUDAMEDEuropa Ultra™ Family EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630033300728 EUDAMED
- Basic UDI-DI
- B-07630033300728 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
Europa Ultra NC - Non-Compliant Coronary Balloon Catheter 2.25mmx15mm by Rontis Corporation SA — Class III — MDR, MDD — listed in EUDAMED
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-07630033300728 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-07630033300728 | 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 5bf3443c-9e6b-4cc9-ae11-388c8f99e6cf 61 fields · synced Jun 20, 2026
- EUDAMED 0a9d344d-deac-4231-a8b6-bb962377ea17 61 fields · synced May 19, 2026