United Kingdom MHRA device registration 102590

CPAP/BPAP face mask, single-use

United Kingdom·General Medical Device·Engineered Medical Systems, Inc dba Pulmodyne·Registered Nov 26, 2024

Registration details

Device ID: 102590
MHRA Reference Number: 102590
Date Registered: Nov 26, 2024
Last Updated: Nov 7, 2023

Device classification

Device Type: General Medical Device
Devices: CPAP/BPAP face mask, single-use
Type: Class IIa

Manufacturer

Name: Engineered Medical Systems, Inc dba Pulmodyne
Address: 2055 Executive Drive
Indianapolis, Indianapolis, United States
Created Date: Sep 3, 2021

Authorized Representative

Name: QNET Ltd
Relationship Type: UK Responsible Person
Address: Livingstone House 309 Harrow Road
Wembley, Middlesex, England, United Kingdom
Postcode: HA9 6BD

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About this record

CPAP/BPAP face mask, single-use is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 102590. The device is manufactured by Engineered Medical Systems, Inc dba Pulmodyne from United States, classified as General Medical Device. The authorized representative in the UK is QNET Ltd.

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