Singapore HSA registration DE0507651
Shenzhen Mindray Mindray Ventilator
Singapore·CLASS C·Shenzhen Mindray Bio-Medical Electronics Co., Ltd·Registered January 04, 2023Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0507651
- Registration Date
- January 04, 2023
- Retention Due Date
- January 03, 2026
Product description
The SV600/SV800 Mindray Ventilator is intended to be used in intensive care situations within a professional healthcare facility, or during transport within a professional healthcare facility. This product is intended to provide ventilation assistance and breathing support for adult, paediatric and neonate patients. The product should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.
Product Owner
- Short Name
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd
- Address
- Mindray Building,, Keji 12th Road South,, Hi-Tech Industrial Park, Nanshan,, Shenzhen, Guangdong, 518057, CHINA
Registrant
- Address
- 219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
- Address
- 219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Model information
- Model Name(s)
- Single-Patient Uses Adult Airway Adapter Single-Patient Uses Neonatal Airway Adapter Sensor Magnetic O2 0-100% Aanlog Airway Adapter, Neonate Oxygen Sensor MOX-3 Spirometry Flow Sensor, Neonatal, 1.8m Disinfected Assembly of Expiration Valve The Disposable Part of Safety Module Reusable SpO2 Sensor, Adt, Finger-Clip Reusable SpO2 Sensor, Pdt, Finger-Clip Reusable SpO2 Sensor, Neo/Pdt/Adt, Bandage Dryline airway adapter, straight Sampling line, Adu/Ped, 2.5 m Sampling line, Neo, 2.5m Ventilator Ventilator
- Model Identifier(s)
- 0010-10-42662 0010-10-42664 012-000177-00 040-001187-00 040-001275-00 040-001948-00 115-021461-00 115-021478-00 512F-30-28263 512H-30-79061 518B-30-72107 9000-10-07486 9200-10-10533 9200-10-10555 SV600 SV800
About this record
Access comprehensive regulatory information for Shenzhen Mindray Mindray Ventilator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507651 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The device was registered on January 04, 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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