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Fisher & Paykel Oracle Oral Mask - HSA Registration DE0002348

Access comprehensive regulatory information for Fisher & Paykel Oracle Oral Mask in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0002348 and owned by Fisher & Paykel Healthcare Ltd.. The device was registered on December 05, 2005.

This page provides complete registration details including product owner information, registrant details, 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
DE0002348
Fisher & Paykel Oracle Oral Mask
HSA Registration Number: DE0002348
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Product Description

It is intended for adult patient use by individuals who have been diagnosed by a physician as requiring CPAP or Bilevel ventilator treatment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00102
HS Code
90200000
Registration Information
Registration Number
DE0002348
Registration Date
December 05, 2005
Retention Due Date
December 31, 2025
Product Owner
Short Name
Fisher & Paykel
Address
15 Maurice Paykel Place, East Tamaki, Auckland, NEW ZEALAND
Registrant
Address
3 UPPER ALJUNIED LINK, JOO SENG WAREHOUSE, #07-06, SINGAPORE 367902
Model Information
Model Name(s)
Fisher & Paykel Oracle Oral Mask
Model Identifier(s)
HC451