Singapore HSA registration DE0013040
Respironics BiPAP A40
Singapore·CLASS C·Respironics, Inc.·Registered May 29, 2013Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Anaesthesiology
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90192000
Registration information
- Registration Number
- DE0013040
- Registration Date
- May 29, 2013
- Change Notification Approval Date
- November 23, 2021
- Retention Due Date
- May 28, 2025
Product description
The BiPAP A40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA), Respiratory Insufficiency, or Respiratory Failure. It is intended to be used in home, institutional/hospital, and portable applications such as wheelchairs and gurneys. It is not intended to be used as a transport ventilator, and is not intended for life support.
Product Owner
- Short Name
- Respironics, Inc.
- Address
- 1001 Murry Ridge Lane, Murrysville, PA 15668, UNITED STATES
Registrant
- Address
- 622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
- Address
- 25 LI HWAN TERRACE, GOLDEN HILL ESTATE, SINGAPORE 556953 17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880 622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763 2 VENTURE DRIVE, VISION EXCHANGE, #22-28, SINGAPORE 608526
Model information
- Model Name(s)
- Performance tubing 22 mm Detachable Battery Foam filter kit Ultra-fine filter kit Performance tubing 15 mm RESPIRONICS BIPAP A40 RESPIRONICS BIPAP A40, Core Package System One A-Series Heated Humidifier 1/4" nurse call cable, Close 1/4" nurse call cable, Open Nurse call cable open ends Battery Module Respironics BiPAP A40 Ventilator International A Series System One Heated Humidifier International A Series System One Heated Tube Humidifier International
- Model Identifier(s)
- 1032907 1043570 1063091 1063096 1074400 1076493 1076566 1077107 1080247 1080248 1080249 1096770 1111169 1111552 1111555
About this record
Access comprehensive regulatory information for Respironics BiPAP A40 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0013040 and owned by Respironics, Inc.. The device was registered on May 29, 2013.
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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