Singapore HSA registration DE0505925
Vapotherm Precision Flow Hi-VNI Oxygen Therapy System
Singapore·CLASS B·Vapotherm Inc.·Registered June 24, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0505925
- Registration Date
- June 24, 2021
- Change Notification Approval Date
- July 09, 2024
- Retention Due Date
- June 23, 2025
Product description
Precision Flow® Hi-VNI is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings.
Product Owner
- Name
- Vapotherm Inc.
- Short Name
- Vapotherm Inc.
- Address
- 100 Domain Drive, Ste 102, Exeter, NH 03833, UNITED STATES
Registrant
- Address
- 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Importer
- Address
- 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Model information
- Model Name(s)
- Vapotherm High Velocity Nasal Cannula (Adult) Vapotherm High Velocity Nasal Cannula (Infant) Vapotherm High Velocity Nasal Cannula (Intermediate Infant) Vapotherm High Velocity Nasal Cannula (Premature) Vapotherm High Velocity Nasal Cannula (Neonatal) Vapotherm High Velocity Nasal Cannula (Pediatric/Adult Small) Vapotherm High Velocity Nasal Cannula (Pediatric Small) Aerosol Disposable Patient Circuit [ADPC-(HIGH)] Aerosol Disposable Patient Circuit [ADPC-(LOW)] Precision Flow Disposable Patient Circuit - High Flow (DPC-HIGH) Precision Flow Disposable Patient Circuit - Low Flow (DPC-LOW) Precision Flow Hi-VNI ProSoft High Velocity Nasal Cannula (Adult) ProSoft Hi-VNI Nasal Cannula (Infant) ProSoft Hi-VNI Nasal Cannula (Intermediate Infant) ProSoft High Velocity Nasal Cannula (Neonatal) ProSoft Hi-VNI Nasal Cannula (Pediatric Small) ProSoft High Velocity Nasal Cannula (Premature) ProSoft High Velocity Nasal Cannula (Pediatric/Adult Small) ProSoft High Velocity Nasal Cannula (Adult Long) Vapotherm High Velocity Nasal Cannula (Premature, Neonatal, Infant)
- Model Identifier(s)
- MA1700 MI1300 MI1300B MN1100A MN1100B MP1500 MPS1500 PF-ADPC-HIGH PF-ADPC-LOW PF-DPC-HIGH PF-DPC-LOW PF-PLUS ProSoft-ADULT ProSoft-INF ProSoft-INT-INF ProSoft-NEO ProSoft-PED-S ProSoft-PRE ProSoft-Ped-AS ProSoft-XL SOLO1300
About this record
Access comprehensive regulatory information for Vapotherm Precision Flow Hi-VNI Oxygen Therapy 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 DE0505925 and owned by Vapotherm Inc.. The device was registered on June 24, 2021.
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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