Singapore HSA registration DE0013594
Respironics BiPAP autoSV AVD System One 60 Series
Singapore·CLASS C·Respironics, Inc.·Registered August 12, 2013Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
- HSA Product Code
- HSAMDC00102
- HS Code
- 90200000
Registration information
- Registration Number
- DE0013594
- Registration Date
- August 12, 2013
- Change Notification Approval Date
- November 23, 2021
- Retention Due Date
- August 11, 2025
Product description
The BiPAP autoSV Advanced System One device is intended to provide mask-applied non-invasive ventilatory support to adult patients (>30 kg) for the primary treatment of obstructive sleep-disordered breathing with secondary Central Sleep Apnea or Cheyne-Stokes Respiration (CSR). The 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)
- Power cord UK Water chamber 80 watt power supply Upgrade kit Heated humidifier standard Heated tube humidifier BiPAP autoSV AVD System One 60 Series w/ Humid, Intl BiPAP autoSV AVD System One 60 Series, Intl BiPAP autoSV AVD System One 60 Series w/HT Humid, Intl System One Heated Tube
- Model Identifier(s)
- 1039026 1063785 1091399 6T-CONVKIT IN6H IN6T IN961HS IN961S IN961TS SYS1HT15
About this record
Access comprehensive regulatory information for Respironics BiPAP autoSV AVD System One 60 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 DE0013594 and owned by Respironics, Inc.. The device was registered on August 12, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C