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Pulmodyne Aero-Pro™ Filters - HSA Registration DE0504349

Access comprehensive regulatory information for Pulmodyne Aero-Pro™ 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 DE0504349 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
DE0504349
Pulmodyne Aero-Pro™ Filters
HSA Registration Number: DE0504349
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Product Description

The filters are intended for use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0504349
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-Pro S™ Filter (Sterile) Aero-Pro S™ Filter Aero-Pro™ Filter Small Angled (Sterile) Aero-Pro™ Filter Small Angled Aero-Pro™ Filter Compact Straight (Sterile) Aero-Pro™ Filter Compact Straight Aero-Pro™ Filter Compact Angled (Sterile) Aero-Pro™ Filter Compact Angled Aero-Pro™ Filter Small Straight (Sterile) Aero-Pro™ Filter Small Straight Aero-Pro™ HEPA Light w Port (Sterile) Aero-Pro™ HEPA Light w/ Port Aero-Pro™ HEPA Light (Sterile) Aero-Pro™ HEPA Light Aero-Pro™ HEPA Light Machine (Sterile) Aero-Pro™ HEPA Light Machine Aero-Pro™ HEPA Small Angled (Sterile) Aero-Pro™ HEPA Small Angled Aero-Pro™ HEPA Small Straight (Sterile) Aero-Pro™ HEPA Small Straight
Model Identifier(s)
200101 200102 200201 200202 200301 200302 200401 200402 200601 200602 201001 201002 201011 201012 201021 201022 20151 20152 20161 20162