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Medkonsult Uromic Urodynamic Systems - HSA Registration DE0504861

Access comprehensive regulatory information for Medkonsult Uromic Urodynamic Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504861 and owned by Medkonsult medical technology s.r.o.. The device was registered on August 26, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0504861
Medkonsult Uromic Urodynamic Systems
HSA Registration Number: DE0504861
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Product Description

Intended for complete urodynamic examination performed in urological examination rooms. It can be used for diagnostics of urinary tract using standard measuring methods stated by ICS. โ€ข The following measurement methods are implemented for UROMIC Tango16, UROMIC Quickstep: uroflowmetry, cystometry, miction cystometry, profilometry, VLPP, EMG โ€ข The following measurement methods are implemented for UROMIC Samba, UROMIC Jive, UROMIC Blues: uroflowmetry, cystometry, miction cystometry, profilometry, VLPP, EMG, anorectal manometry

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0504861
Registration Date
August 26, 2020
Retention Due Date
August 25, 2025
Product Owner
Short Name
Medkonsult medical technology s.r.o.
Address
Pasteurova 67/15, Klasterni Hradisk, 77900 Olomouc Czech Republic, CZECH REPUBLIC
Registrant
Address
82 UBI AVENUE 4, EDWARD BOUSTEAD CENTRE, #08-01, SINGAPORE 408832
Importer
Address
82 UBI AVENUE 4, EDWARD BOUSTEAD CENTRE, #08-01, SINGAPORE 408832
Model Information
Model Name(s)
UROMIC Blues UROMIC Jive UROMIC QuickStep UROMIC Samba UROMIC Tango 16
Model Identifier(s)
UROMIC Blues UROMIC Jive UROMIC QuickStep UROMIC Samba UROMIC Tango 16