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Pulmodyne AccuPAP Positive Airway Pressure System - HSA Registration DE0504055

Access comprehensive regulatory information for Pulmodyne AccuPAP Positive Airway Pressure System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504055 and owned by Pulmodyne, Inc.. The device was registered on January 22, 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
DE0504055
Pulmodyne AccuPAP Positive Airway Pressure System
HSA Registration Number: DE0504055
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Product Description

The AccuPAP is a positive airway pressure therapy system device that is indicated for the prevention or reversal of atelectasis. It may also be used to optimize delivery of aerosolized medication when utilized with a small nebulizer

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0504055
Registration Date
January 22, 2020
Retention Due Date
January 21, 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)
DPM Disposable Pressure Manometer AccuPAP AccuPAP with Disposable Pressure Manometer
Model Identifier(s)
313-5558 313-6000 313-6001