Singapore HSA registration DE0012008
Respironics BiPAP A30
Singapore·CLASS C·Respironics, Inc.·Registered December 28, 2012Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90192000
Registration information
- Registration Number
- DE0012008
- Registration Date
- December 28, 2012
- Change Notification Approval Date
- November 23, 2021
- Retention Due Date
- December 27, 2025
Product description
The BiPAP A30 ventilator is intended to provide non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (22 lbs) with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. It is intended to be used in both the home and clinical settings, such as hospitals, sleep laboratories, sub-acute care institutions.
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 Foam filter kit Ultra-fine filter kit Water chamber Performance tubing 15 mm High Performance/Low Power Oximetry Module Respironics BiPAP A30 Ventilator Respironics BiPAP A30 Ventilator with Humidifier System One A-Series Heated Humidifier LNCS DCIP, Pediatric Reusable Sensor (10-50 kg) LNCS DBI, Adult Soft Reusable Sensor LNCS Adtx, Adult Disposable Sensor, 20/box (> 30 kg) LNCS Pdtx, Pediatric Disposable Sensor, 20/box (10-50 kg) LNCS Inf, Infant Disposable Sensor, 20/box (3-20 kg) LNCS DCI, Adult Reusable Sensor (> 30 kg) LNCS YI, Multisite Reusable Sensor (> 1 kg) Respironics BiPAP A30 Ventilator A Series System One Heated Humidifier International A Series System One Heated Tube Humidifier International
- Model Identifier(s)
- 1032907 1063091 1063096 1066737 1074400 1075383 1076491 1076564 1077107 1081515 1081516 1081517 1081518 1081519 1081984 1081985 1111143 1111552 1111555
About this record
Access comprehensive regulatory information for Respironics BiPAP A30 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0012008 and owned by Respironics, Inc.. The device was registered on December 28, 2012.
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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