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Singapore HSA registration DE0011411

Philips Respironics NIVO/ Pro- X Nebulizer System

Singapore flagSingapore·CLASS B·Philips Respironics, Inc.·Registered October 22, 2012
Device classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration information
Registration Number
DE0011411
Registration Date
October 22, 2012
Retention Due Date
October 21, 2025
Product description
It is a portable medical device that is intended to aerosolize physician-prescribed solutions for inhalation to patients on ventilation or other positive pressure breathing assistance.
Product Owner
Name
Philips Respironics, Inc.
Short Name
Philips Respironics, Inc.
Address
1010 Murry Ridge Lane, Murrysville, PA, 15668, UNITED STATES
Registrant
Name
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Name
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model information
Model Name(s)
AF531 EE Leak 1 4PT HDG - Small AF531 EE Leak 1 4PT HDG - Medium AF531 EE Leak 1 4PT HDG - Large AF531 SE 4PT HDG - Small AF531 SE 4PT HDG - Medium AF531 SE 4PT HDG - Large AF531 EE Leak 1 CapStrap - Small AF531 EE Leak 1 CapStrap - Medium AF531 EE Leak 1 CapStrap - Large AF531 SE CapStrap - Small AF531 SE CapStrap - Medium AF531 SE CapStrap - Large AF531 EE Leak1 NE 4PT HDG, SU - Small AF531 EE Leak1 NE 4PT HDG, SU - Medium AF531 EE Leak1 NE 4PT HDG, SU - Large AF531 EE Leak1 NE CapStrap, SU - Small AF531 EE Leak1 NE CapStrap, SU - Medium AF531 EE Leak1 NE CapStrap, SU - Large AF531 EE Leak 1, CKT 4PT HDG - Small AF531 EE Leak 1, CKT 4PT HDG - Medium AF531 EE Leak 1, CKT 4PT HDG - Large AF531 EE Leak1, CKT, NE CapStrap, SU - Small AF531 EE Leak1, CKT, NE CapStrap, SU - Medium AF531 EE Leak1, CKT, NE CapStrap, SU - Large EE Nebulizing Elbow Kit, Single EE Nebulizing Elbow Kit Bronchoscopy Elbow, Single Bronchoscopy Elbow NIVO Generator, SE Elbow, 5 Pack NIVO Generator, EE Elbow, 5 Pack SE Nebulizing Elbow Kit SE Nebulizing Elbow Kit, Single NIVO/Pro-X Controller Kit NIVO/Pro-X Nebulizer System
Model Identifier(s)
1072621 1072622 1072623 1072624 1072625 1072626 1072627 1072628 1072629 1072630 1072631 1072632 1072633 1072634 1072635 1072636 1072637 1072638 1072639 1072640 1072641 1072642 1072643 1072644 1072649 1072650 1072651 1072652 1076303 1076304 1076754 1076755 1079421 1079422 1079424 1079425 1079426 1079468
About this record

Access comprehensive regulatory information for Philips Respironics NIVO/ Pro- X Nebulizer 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 DE0011411 and owned by Philips Respironics, Inc.. The device was registered on October 22, 2012.

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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