Singapore HSA registration DE0504061
Pulmodyne Aero-Sat™ Heat Moisture Exchanger/Filters
Singapore·CLASS B·Pulmodyne, Inc.·Registered January 23, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Anaesthesiology
Registration information
- Registration Number
- DE0504061
- Registration Date
- January 23, 2020
- Retention Due Date
- January 22, 2026
Product description
The Heat Moisture Exchanger (HME) is intended to provide humidification during breathing through artificial airways. The combined HMEF is intended to provide humidification and filtration during breathing through artificial airways. Expert clinical judgement must be used in assessing the patients' humidification requirements.
Product Owner
- Name
- Pulmodyne, Inc.
- Short Name
- Pulmodyne, Inc.
- Address
- 2055 Executive Dr, Indianapolis, IN 46241, Indiana, UNITED STATES
Registrant
- Address
- 31 KAKI BUKIT ROAD 3, TECHLINK, #05-12, SINGAPORE 417818
Importer
- Address
- 31 KAKI BUKIT ROAD 3, TECHLINK, #05-12, SINGAPORE 417818
Model information
- Model Name(s)
- Aero-Sat™ 1 Straight (Sterile) Aero-Sat™ 1 Straight Aero-Sat™ 1 Straight w/Port (Sterile) Aero-Sat™ 1 Straight w/Port Aero-Sat™ 2 Angled (Sterile) Aero-Sat™ 2 Angled Aero-Sat™ 2 Straight (Sterile) Aero-Sat™ 2 Straight Aero-Sat™ Mini (Sterile) Aero-Sat™ Mini Aero-Sat™ Micro + 3.0 (Sterile) Aero-Sat™ Micro + 3.0 Aero-Sat™ Micro + 3.5 (Sterile) Aero-Sat™ Micro + 3.5 Aero-Sat™ Filter Compact Straight (Sterile) Aero-Sat™ Filter Compact Straight Aero-Sat™ Filter Compact Angle (Sterile) Aero-Sat™ Filter Compact Angle Aero-Sat™ Filter Pedi (Sterile) Aero-Sat™ Filter Pedi Aero-Sat™ Filter Small Straight (Sterile) Aero-Sat™ Filter Small Straight Aero-Sat™ Filter Small Angled (Sterile) Aero-Sat™ Filter Small Angled Aero-Sat™HEPA (Sterile) Aero-Sat™HEPA
- Model Identifier(s)
- 101 102 201 202 401 402 601 602 701 702 1101 1102 1201 1202 100801 100802 100901 100902 101001 101002 102301 102302 102401 102402 102901 102902
About this record
Access comprehensive regulatory information for Pulmodyne Aero-Sat™ Heat Moisture Exchanger/Filters in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504061 and owned by Pulmodyne, Inc.. The device was registered on January 23, 2020.
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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