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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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Agitator - Irrigation Steerable… — 1 UDI-DI variant, MDR

MD Atlas
Calyx Medical Sp. z o.o.

Data from EUDAMED, last updated May 30, 2026

Agitator - Irrigation Steerable Catheter

59061689422URO059LJ

1 UDI-DI variant

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Calyx Medical Sp. z o.o.

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Device characteristics

No device characteristics flagged

Clinical investigations

Investigation number: W/SFRS/1
Registered: No
Countries: South Africa

Identity & classification

Basic UDI-DI: 59061689422URO059LJ
Device name: Agitator - Irrigation Steerable Catheter
Device model: URO 059
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Mar 1, 2024

Manufacturer & authorised representative

Manufacturer

Name: Calyx Medical Sp. z o.o.
SRN: PL-MF-000038787
Country: Poland
Email: biuro@wismedpl.com
Phone: +48 882592872

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01HQWCZEJR1H4CF3H7TX8NXEBV

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

Agitator05906168942266