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Singapore HSA registration DE0508440

Vapotherm Vapotherm Oxygen Assist Module (OAM)

Singapore flagSingapore·CLASS C·Vapotherm Inc.·Registered August 28, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508440
Registration Date
August 28, 2023
Retention Due Date
August 27, 2025
Product description
The Oxygen Assist Module is an optional module used only with the Vapotherm Precision Flow and is indicated for on-demand titration of oxygen into warm humidified breathing gases delivered to spontaneously breathing patients based on continuous non-invasive monitoring of blood oxygen saturation. The Oxygen Assist Module is intended to treat pediatric (including neonatal) and adult patients in monitored clinical environments.
Product Owner
Name
Vapotherm Inc.
Short Name
Vapotherm Inc.
Address
100 Domain Drive, Ste 102, Exeter, NH 03833, UNITED STATES
Registrant
Name
EO MEDICAL PTE. LTD.
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Importer
Name
EO MEDICAL PTE. LTD.
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Model information
Model Name(s)
Vapotherm Oxygen Assist Module Vapotherm Oxygen Assist Module
Model Identifier(s)
PF-OAM-MAS PF-OAM-NEL
About this record

Access comprehensive regulatory information for Vapotherm Vapotherm Oxygen Assist Module (OAM) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508440 and owned by Vapotherm Inc.. The device was registered on August 28, 2023.

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 C