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Oruba Oruflow - HSA Registration DE0509843

Access comprehensive regulatory information for Oruba Oruflow in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509843 and owned by ORUBA MEDİKAL TEKNOLOJİ ARGE İÇ VE DIŞ TİCARET ANONİM ŞİRKETİ. The device was registered on September 26, 2024.

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
DE0509843
Oruba Oruflow
HSA Registration Number: DE0509843
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Product Description

Follow-up of patients with lower urinary tract symptoms (LUTS) and patients who have undergone an operation for voiding dysfunction. Diagnosing voiding disorders such as urinary incontinence, frequent urination, inability to urinate, forced or drip urination.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509843
Registration Date
September 26, 2024
Retention Due Date
September 25, 2025
Product Owner
Short Name
ORUBA MEDİKAL TEKNOLOJİ ARGE İÇ VE DIŞ TİCARET ANONİM ŞİRKETİ
Address
Üniversiteler Mahallesi İhsan, Doğramacı Bulvarı No:29 İç, Kapı No:Z02 Çankaya, Ankara, TURKEY
Registrant
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Importer
Address
196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384
Model Information
Model Name(s)
Oruflow - EMG Self Operating Uroflowmeter System / Optional EMG Module Oruflow-Main Self-Operating Uroflowmeter Oruflow-Master Self-Operating Uroflowmeter Oruflow Toilet-EMG Self-Operating Uroflowmeter System / Optional EMG Module Oruflow Toilet-Main Self-Operating Uroflowmeter Oruflow Toilet-Master Self-Operating Uroflowmeter
Model Identifier(s)
ORUFLOW-EMG ORUFLOW-Main ORUFLOW-Master Oruflow Toilet-EMG Oruflow Toilet-Main Oruflow Toilet-Master