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Fisher & Paykel Healthcare Optiflow+ Duet nasal cannula - HSA Registration DE0509764

Access comprehensive regulatory information for Fisher & Paykel Healthcare Optiflow+ Duet nasal cannula in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509764 and owned by Fisher & Paykel Healthcare Ltd.. The device was registered on September 09, 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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CLASS B
DE0509764
Fisher & Paykel Healthcare Optiflow+ Duet nasal cannula
HSA Registration Number: DE0509764
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Product Description

Nasal cannula patient interface for delivery of humidified respiratory gases.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0509764
Registration Date
September 09, 2024
Change Notification Approval Date
October 01, 2024
Retention Due Date
September 08, 2025
Product Owner
Short Name
Fisher & Paykel Healthcare Ltd.
Address
15 Maurice Paykel Place, East Tamaki, Auckland 2013, NEW ZEALAND
Registrant
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880 37 UBI CRESCENT, SINGAPORE 408586 3 UPPER ALJUNIED LINK, JOO SENG WAREHOUSE, #07-06, SINGAPORE 367902
Model Information
Model Name(s)
F&P Optiflow+ Duet, myAirvo F&P Optiflow+ Duet, myAirvo F&P Optiflow+ Duet, myAirvo F&P Optiflow+ Duet, Nasal Cannula - F&P Optiflow+ Duet, Nasal Cannula - F&P Optiflow+ Duet, Nasal Cannula -
Model Identifier(s)
MYDUETLARGE MYDUETMEDIUM MYDUETSMALL OPT962 OPT964 OPT966