Singapore HSA registration DE0509268

Pulmodyne GO-PAP

Singapore·CLASS B·Pulmodyne, Inc.·Registered May 08, 2024

Device classification

Device Class: CLASS B
Medical Speciality Area: Anaesthesiology

Registration information

Registration Number: DE0509268
Registration Date: May 08, 2024
Retention Due Date: May 07, 2026

Product description

Pulmodyne’s Go-PAP delivers continuous positive airway pressure (CPAP) throughout the breathing cycle. It provides CPAP at preset levels throughout inspiration and exhalation, independent of the patient’s flow rate. Go-PAP system is intended for use on spontaneously breathing patients.

Product Owner

Name: Pulmodyne, Inc.
Short Name: Pulmodyne, Inc.
Address: 2055 Executive Dr, Indianapolis, IN 46241, Indiana, UNITED STATES

Registrant

Name: I:EMEDICS PTE. LTD.
Address: 31 KAKI BUKIT ROAD 3, TECHLINK, #05-12, SINGAPORE 417818

Importer

Name: I:EMEDICS PTE. LTD.
Address: 31 KAKI BUKIT ROAD 3, TECHLINK, #05-12, SINGAPORE 417818

Model information

Model Name(s): Neb-Connect GO-PAP, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Small) GO-PAP with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Small) GO-PAP, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium) GO-PAP with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium) GO-PAP plus Neb-Connect, with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium) GO-PAP, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large) GO-PAP with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large) GO-PAP plus Neb-Connect, with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large) GO-PAP, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium) GO-PAP with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium) GO-PAP plus Neb-Connect, with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Medium) GO-PAP, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large) GO-PAP with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large) GO-PAP plus Neb-Connect, with Included Nebulizer, 5.0/7.5/10.0cm PEEP Levels, BiTrac ED Mask (Adult Large)
Model Identifier(s): 313-011111 313-4601 313-4601N 313-4602 313-4602N 313-4602NC 313-4603 313-4603N 313-4603NC 313-4604 313-4604N 313-4604NC 313-4605 313-4605N 313-4605NC

About this record

Access comprehensive regulatory information for Pulmodyne GO-PAP in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509268 and owned by Pulmodyne, Inc.. The device was registered on May 08, 2024.

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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