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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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Sterile Stone Extraction Balloon… — 2 UDI-DI variants, MDR

MD Atlas
G-FLEX FLEXIBLE INSTRUMENTS EUROPE

Data from EUDAMED, last updated May 23, 2026

Sterile Stone Extraction Balloon Catheter

54200513-TF13-XTB-SU-MM

2 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: G-FLEX FLEXIBLE INSTRUMENTS EUROPE

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 54200513-TF13-XTB-SU-MM
Device name: Sterile Stone Extraction Balloon Catheter
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Mar 26, 2026

Manufacturer & authorised representative

Manufacturer

Name: G-FLEX FLEXIBLE INSTRUMENTS EUROPE
SRN: BE-MF-000000623
Country: Belgium
Email: thierry@g-flex.com
Phone: +3267883665

Variants by status

UDI-DI variants

2 UDI-DI variants

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basicUdiUlid01KMMHNRZF622QG7JATDBZY5M7

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

Sterile Stone Extraction Balloon Catheter05420051300594
Sterile Stone Extraction Balloon Catheter05420051302833