Singapore HSA registration DE0014695
Respironics BiPAP AVAPS C Series
Singapore·CLASS C·Respironics, Inc.·Registered January 27, 2014Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0014695
- Registration Date
- January 27, 2014
- Change Notification Approval Date
- November 23, 2021
- Retention Due Date
- January 26, 2026
Product description
The BiPAP AVAPS device is intended to provide non-invasive ventilatory support to treat adult patients weighing over 30 kg (66 lbs) and pediatric patients 7 years or older and weighing over 18 kg (40 lbs) with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. This device may be used in the hospital or home.
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)
- DirectView PC Software Application, SD Card, and SD Card Mailer Power Cord W/C7 End, 5FT (1.5 meters) SD card reader EncorePro 2 Software DirectView PC Software Application, Web Software System One heated humidifier Power Supply Link module Foam filter kit Ultra-fine filter kit Philips Respironics CPAP / BiPAP Side Panel Carrying case SD card cover Philips RI SD Cards 10Pk Q-Series SD Card Mailer, 10pack - (Dom) Water chamber BiPAP AVAPS C Series, International BiPAP AVAPS C Series, International 30 System One Heated Humidifier INT System One Heated Tube Humidifier INT
- Model Identifier(s)
- 1005297 1039026 1047300 1054785 1055635 1056210 1058190 1061644 1063091 1063096 1063784 1063857 1063858 1063859 1065146 1066737 IN1161S IN1161X IN6H IN6T
About this record
Access comprehensive regulatory information for Respironics BiPAP AVAPS C Series in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0014695 and owned by Respironics, Inc.. The device was registered on January 27, 2014.
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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