Singapore HSA registration DE0014472
PULMODYNE BITRAC NASAL MASKS & ACCESSORIES
Singapore·CLASS B·Pulmodyne, Inc.·Registered December 17, 2013Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
- HSA Product Code
- HSAMDB00102
- HS Code
- 90200000
Registration information
- Registration Number
- DE0014472
- 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
- Address
- 31 KAKI BUKIT ROAD 3, TECHLINK, #05-12, SINGAPORE 417818
Importer
- Address
- 31 KAKI BUKIT ROAD 3, TECHLINK, #05-12, SINGAPORE 417818
Model information
- Model Name(s)
- BiTrac Nasal Mask BiTrac Nasal Mask BiTrac Nasal Mask BiTrac Nasal Mask Head Strap with 2 clips (Black) Full Cap Head Gear with 2 clips (Black) BiTrac SE Select Nasal Mask Chin Strap (Black) BiTrac SE Select Nasal Mask BiTrac SE Select Nasal Mask BiTrac SE Select Nasal Mask BiTrac SE Select Nasal Mask BiTrac SE Select Nasal Mask BiTrac Circuit BiTrac Circuit ValueTrac Circuit BiTrac Select Interchangable Anti-Asphyxia Elbow BiTrac SE Select Interchangable Standard Elbow
- Model Identifier(s)
- 313-9013W 313-9014W 313-9015W 313-9016W 313-9026 313-9027 313-9028W 313-9029 313-9030W 313-9039W 313-9040W 313-9041W 313-9049W 313-9074 313-9075 313-9078 313-9598 313-9599
About this record
Access comprehensive regulatory information for PULMODYNE BITRAC 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 DE0014472 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.
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