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Singapore HSA registration DE0014473

PULMODYNE VALUETRAC NASAL MASKS & ACCESSORIES

Singapore flagSingapore·CLASS B·Pulmodyne, Inc.·Registered December 17, 2013
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00102
HS Code
90200000
Registration information
Registration Number
DE0014473
Registration Date
December 17, 2013
Retention Due Date
December 16, 2025
Product description
Used with and attached to a positive pressure air source, CPAP or Bilevel equipment, and has the Indications for Use consistent with the Indications for Use of the equipment to which it is attached.
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)
ValueTrac NIV Nasal Mask ValueTrac NIV Nasal Mask ValueTrac NIV Nasal Mask ValueTrac NIV Nasal Mask Head Strap with 2 clips (Black) Full Cap Head Gear with 2 clips (Black) Chin Strap (Black) BiTrac Circuit BiTrac Circuit ValueTrac Circuit BiTrac Select Interchangable Anti-Asphyxia Elbow BiTrac SE Select Interchangable Standard Elbow
Model Identifier(s)
313-9017 313-9018 313-9019 313-9020 313-9026 313-9027 313-9029 313-9074 313-9075 313-9078 313-9598 313-9599
About this record

Access comprehensive regulatory information for PULMODYNE VALUETRAC NASAL MASKS & ACCESSORIES in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014473 and owned by Pulmodyne, Inc.. The device was registered on December 17, 2013.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B