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Vapotherm Precision Flow Hi-VNI Oxygen Therapy System - HSA Registration DE0505925

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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CLASS B
DE0505925
Vapotherm Precision Flow Hi-VNI Oxygen Therapy System
HSA Registration Number: DE0505925
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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.

Device 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 Owner
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