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Pulmodyne Aero-T Heat Moisture Exchangers - HSA Registration DE0504350

Access comprehensive regulatory information for Pulmodyne Aero-T Heat Moisture Exchangers in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504350 and owned by Pulmodyne, Inc.. The device was registered on April 08, 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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CLASS B
DE0504350
Pulmodyne Aero-T Heat Moisture Exchangers
HSA Registration Number: DE0504350
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Product Description

The Heat Moisture Exchanger (HME) is intended to provide humidification during breathing through artificial airways. Expert clinical judgement must be used in assessing the patients' humidification requirements.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0504350
Registration Date
April 08, 2020
Retention Due Date
April 07, 2026
Product Owner
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-T (Sterile) Aero-T Aero-T+ (Sterile) Aero-T+
Model Identifier(s)
300101 300102 301101 301102