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Shenzhen Browiner Tech MobileCooper Digital Radiography System - HSA Registration DE0509451

Access comprehensive regulatory information for Shenzhen Browiner Tech MobileCooper Digital Radiography System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509451 and owned by Shenzhen Browiner Tech Co., Ltd. The device was registered on June 24, 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 C
DE0509451
Shenzhen Browiner Tech MobileCooper Digital Radiography System
HSA Registration Number: DE0509451
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Product Description

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509451
Registration Date
June 24, 2024
Retention Due Date
June 23, 2025
Product Owner
Short Name
Shenzhen Browiner Tech Co., Ltd
Address
Room 501, Building C, Ganghongji, High-Tech Intelligent Industrial Pk, No.1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District, 518055 Shenzhen, CHINA
Registrant
Address
28 SIN MING LANE, MIDVIEW CITY, #02-143, SINGAPORE 573972
Importer
Address
3006 UBI ROAD 1, KAMPONG UBI INDUSTRIAL ESTATE, #02-336, SINGAPORE 408700
Model Information
Model Name(s)
VacuDAP-OEM (optional) MobileCooper Digital Radiography System BWG-50 High Voltage Generator BWS-20 Image Acquisition Workstation BWT-001 Mobile Flat Bed (optional) CS-06 Chest Bucky Stand (optional) CareView 1500Cwe X-ray Flat Panel Detector (optional) Mars1417V-TSI Wireless Digital Flat Panel Detector (optional)
Model Identifier(s)
150 00 15 801080052 BWG-50 BWS-20 BWT-001 CS-06 CareView 1500Cwe Mars1417V- TSI