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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Europa Ultra Coronary Balloon Catheter — 110 UDI-DI variants, MDR

MD Atlas
Rontis Corporation SA

Data from EUDAMED, last updated May 23, 2026

Europa Ultra Coronary Balloon Catheter

076300333EF_CBLCATHGG

110 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class III

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Manufacturer: Rontis Corporation SA

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 44912221174
Type: refdata.certificate-mdr-type.technical-documentation
Notified body: TÜV NORD CERT GmbH (0044)
Validity: Mar 15, 2024 → Mar 14, 2029

Identity & classification

Basic UDI-DI: 076300333EF_CBLCATHGG
Device name: Europa Ultra Coronary Balloon Catheter
Device model: Europa Ultra™ Family
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Version date: Apr 4, 2024

Manufacturer & authorised representative

Manufacturer

Name: Rontis Corporation SA
SRN: CH-MF-000031411
Country: Switzerland
Email: info@rontis.com

Authorised representative

Name: RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A.
SRN: GR-AR-000023077
Country: Greece
Phone: +302106109090

Variants by status

UDI-DI variants

110 UDI-DI variants

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basicUdiUlid01HTCZ53NH7EFBEV8SEDVHAY0B

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Europa Ultra™07630033300872
Europa Ultra™07630033300766
Europa Ultra™07630033300360
Europa Ultra™07630033300605
Europa Ultra™07630033300254
Europa Ultra™07630033300919
Europa Ultra™07630033300421
Europa Ultra™07630033301107
Europa Ultra™07630033300810
Europa Ultra™07630033300674

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