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Shenzhen Mindray Bio-Medical Electronics Nuewa N9 Diagnostic Ultrasound System - HSA Registration DE0507665

Access comprehensive regulatory information for Shenzhen Mindray Bio-Medical Electronics Nuewa N9 Diagnostic Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507665 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was registered on January 06, 2023.

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
DE0507665
Shenzhen Mindray Bio-Medical Electronics Nuewa N9 Diagnostic Ultrasound System
HSA Registration Number: DE0507665
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Product Description

It is intended for clinical ultrasound diagnosis and examination. It is intended for use in Abdominal, Gynecology, Obstetrics, Pediatric, Cardiac, Small Organ, Musculo-skeletal, Vascular, Nerve, Urology, Intra- operative, Cephalic, Thoracic/Pleural exams. Intended users include doctor, nurse, clinical technologist, radio technologist and ultrasonographer proficient in medicine knowledge. The diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. Intended medical conditions are hospital (e.g., imaging laboratory, emergency room, patient bedside, and operating room), medical clinic, physicianโ€™s office or an imaging center.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0507665
Registration Date
January 06, 2023
Retention Due Date
January 05, 2026
Product Owner
Short Name
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan 518057, CHINA
Registrant
Address
192 PANDAN LOOP, PANTECH BUSINESS HUB, #07-22, SINGAPORE 128381
Importer
Address
192 PANDAN LOOP, PANTECH BUSINESS HUB, #07-22, SINGAPORE 128381
Model Information
Model Name(s)
3C5A Ultrasonic Probe 6CV1 Ultrasonic Probe 6LE7 Ultrasonic Probe 7L4B Ultrasonic Probe 7LT4 Ultrasonic Probe C11-3 Ultrasonic Probe C5-1 Ultrasonic Probe C6-1 Ultrasonic Probe C6-2 Ultrasonic Probe CW2s Ultrasonic Transducer CW5s Ultrasonic Probe D6-2B Ultrasonic Probe D7-2 Ultrasonic Probe DE11-3 Ultrasonic Probe ELC10-4 Ultrasonic Probe L13-3 Ultrasonic Probe L13-3N Ultrasonic Probe L14-3W Ultrasonic Probe L16-4Hs Ultrasonic Probe L20-5s Ultrasonic Probe L9-3 Ultrasonic Probe NGB-004 Needle-guided Bracket NGB-006 Needle-guided Bracket/STEEL NGB-006 Needle-guided Bracket/PLAS NGB-007 Needle-guided Bracket/STEEL NGB-007 Needle-guided Bracket/PLAS NGB-009 Needle-guided Bracket NGB-010 Needle-guided Bracket NGB-011 Needle-guided Bracket NGB-018 Needle-guided Bracket NGB-019 Needle-guided Bracket NGB-022 Needle-guided Bracket NGB-025 Needle-guided Bracket NGB-027 Needle-guided Bracket NGB-034 Needle-guided Bracket NGB-039 Needle-guided Bracket NGB-045 Needle-guided Bracket NGB-048 Needle-guided Bracket NGB-052 Needle-guided Bracket NGB-053 Needle-guided Bracket NGB-054 Needle-guided Bracket Diagnostic Ultrasound System P10-4 Ultrasonic Probe P4-2 Ultrasonic Probe P7-3Ts Ultrasonic Probe P8-2 Ultrasonic Probe P8-2Ts Ultrasonic Transducer P8-3Ts Ultrasonic Probe SC5-1N Ultrasonic Probe SD8-1 Ultrasonic Probe SP5-1N Ultrasonic Probe V10-4 Ultrasonic Probe V10-4B Ultrasonic Probe V11-3 Ultrasonic Probe V11-3B Ultrasonic Probe V11-3H Ultrasonic Probe V11-3HB Ultrasonic Probe
Model Identifier(s)
3C5A 6CV1 6LE7 7L4B 7LT4 C11-3 C5-1 C6-1 C6-2 CW2s CW5s D6-2B D7-2 DE11-3 ELC10-4 L13-3 L13-3N L14-3W L16-4Hs L20-5s L9-3 NGB-004 NGB-006-0022-30-32954 NGB-006-0022-30-90735 NGB-007-0022-30-33013 NGB-007-0022-30-90739 NGB-009 NGB-010 NGB-011 NGB-018 NGB-019 NGB-022 NGB-025 NGB-027 NGB-034 NGB-039 NGB-045 NGB-048 NGB-052 NGB-053 NGB-054 Nuewa N9 P10-4 P4-2 P7-3Ts P8-2 P8-2Ts P8-3Ts SC5-1N SD8-1 SP5-1N V10-4 V10-4B V11-3 V11-3B V11-3H V11-3HB