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Edgecare EdgeFlow UH10 - HSA Registration DE0510299

Access comprehensive regulatory information for Edgecare EdgeFlow UH10 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510299 and owned by Edgecare Inc.. The device was registered on February 04, 2025.

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
DE0510299
Edgecare EdgeFlow UH10
HSA Registration Number: DE0510299
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Product Description

The EdgeFlow UH10 is an ultrasound device intended to be used for measuring the urine volume in the bladder noninvasively. It is intended for use in professional healthcare facilities, such as hospitals, clinics, by qualified and trained healthcare professionals. The EdgeFlow UH10 supports B-mode and harmonic imaging modes.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0510299
Registration Date
February 04, 2025
Retention Due Date
February 03, 2026
Product Owner
Short Name
Edgecare Inc.
Address
#403, Teilhard Hall, 35, Baekbeom-ro, Mapo-gu, Seoul, 04107, KOREA, REPUBLIC OF
Registrant
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Importer
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model Information
Model Name(s)
EdgeFlow UH10 EdgeFlow UH10 Cradle
Model Identifier(s)
UH10201 UH10301