United Kingdom MHRA device registration 86469

Mandible-repositioning sleep-disordered breathing orthosis

United Kingdom flagUnited Kingdom·General Medical Device·ProSomnus Sleep Technologies·Registered Nov 26, 2024
Registration details
Device ID
86469
MHRA Reference Number
86469
Date Registered
Nov 26, 2024
Last Updated
Apr 5, 2024
Device classification
Device Type
General Medical Device
Devices
Mandible-repositioning sleep-disordered breathing orthosis
Type
Class I
Manufacturer
Address
5675 Gibraltar Drive
Pleasanton, CA, United States
Created Date
Jun 25, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
6 Wilmslow Road, Rusholme
Manchester, England, United Kingdom
Postcode: M14 5TP
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About this record

Mandible-repositioning sleep-disordered breathing orthosis is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 86469. The device is manufactured by ProSomnus Sleep Technologies from United States, classified as General Medical Device. The authorized representative in the UK is MDSS-UK RP LIMITED.

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