Singapore HSA registration DE0510299
Edgecare EdgeFlow UH10
Singapore·CLASS B·Edgecare Inc.·Registered February 04, 2025Device 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 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.
Product Owner
- Name
- Edgecare Inc.
- 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
About this record
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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