Europa Ultra CTO - Chronic Total Occlusion Coronary Balloon Catheter OTW 1.5mmx…

EUDAMED

Class III (EU MDR)

Ref EO15/15Model Europa Ultra™ Family

by Rontis Corporation SA

Identity

Trade Name: Europa Ultra™ EUDAMED
Device Name: Europa Ultra CTO - Chronic Total Occlusion Coronary Balloon Catheter OTW 1.5mmx15mm EUDAMED
Europa Ultra Coronary Balloon Catheter EUDAMED
Model / Reference: EO15/15 EUDAMED
Europa Ultra™ Family EUDAMED

Identifiers

Primary DI / UDI-DI: 07630033300643 EUDAMED
Basic UDI-DI: B-07630033300643 EUDAMED
076300333EF_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

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Europa Ultra CTO - Chronic Total Occlusion Coronary Balloon Catheter OTW 1.5mmx… 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-07630033300643	Class III	Active
EUDAMED	European Union	CE/MDD	B-07630033300643	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 b995f1f2-cf2e-4b27-ac78-45be6ff12fc2 61 fields · synced Jul 18, 2026
EUDAMED 98a01d8c-2dfc-496b-9e52-2614cbfd6459 61 fields · synced May 18, 2026