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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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InRo Coronary Balloon Catheter — 110 UDI-DI variants, MDR

MD Atlas
Rontis Corporation SA

Data from EUDAMED, last updated May 23, 2026

InRo Coronary Balloon Catheter

076300333IF_CBLCATHL4

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: 076300333IF_CBLCATHL4
Device name: InRo Coronary Balloon Catheter
Device model: InRo® 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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Applied filters

basicUdiUlid01HTHHH3CWXFR60ZE77FQ3E681

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

InRo®07630033312448
InRo®07630033312684
InRo®07630033313278
InRo®07630033313513
InRo®07630033313001
InRo®07630033312691
InRo®07630033313506
InRo®07630033312844
InRo®07630033312974
InRo®07630033313377
InRo®07630033312806
InRo®07630033313056
InRo®07630033313254
InRo®07630033312660
InRo®07630033313148
InRo®07630033313292
InRo®07630033313315
InRo®07630033313308
InRo®07630033313117
InRo®07630033312486
InRo®07630033313469
InRo®07630033312547
InRo®07630033312615
InRo®07630033312554
InRo®07630033313155

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