Singapore HSA registration DE0016357
Respironics Pico Traditional Nasal Mask
Singapore·CLASS B·Respironics, Inc.·Registered September 29, 2014Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
- HSA Product Code
- HSAMDB00102
- HS Code
- 90200000
Registration information
- Registration Number
- DE0016357
- Registration Date
- September 29, 2014
- Change Notification Approval Date
- September 21, 2021
- Retention Due Date
- September 28, 2025
Product description
This nasal mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
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)
- S/M Pico nasal mask, with headgear L Pico nasal mask, with headgear Xl Pico nasal mask, with headgear S/M Pico nasal mask, without headgear L Pico nasal mask, without headgear XL Pico nasal mask, without headgear Pico headgear clips Pico headgear Pico headgear, reduced size Small/medium nasal cushion Large nasal cushion Extra large nasal cushion Pico sizing gauge S/M,L,XL Pico nasal mask Fitpack, with headgear
- Model Identifier(s)
- 1104915 1104916 1104917 1104918 1104919 1104920 1104933 1104934 1104935 1104936 1104937 1104938 1104939 1104940
About this record
Access comprehensive regulatory information for Respironics Pico Traditional Nasal Mask in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016357 and owned by Respironics, Inc.. The device was registered on September 29, 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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