United Kingdom MHRA device registration 123674

Mandible-repositioning sleep-disordered breathing orthosis

United Kingdom·General Medical Device·SICAT GmbH & Co. KG·Registered Nov 26, 2024

Registration details

Device ID: 123674
MHRA Reference Number: 123674
Date Registered: Nov 26, 2024
Last Updated: Aug 23, 2024

Device classification

Device Type: General Medical Device
Devices: Mandible-repositioning sleep-disordered breathing orthosis
Type: Custom-made - Class I

Manufacturer

Name: SICAT GmbH & Co. KG
Address: Friesdorfer Str. 131-135
Bonn, Germany
Created Date: Oct 4, 2021

Authorized Representative

Name: Dentsply IH Limited
Relationship Type: UK Responsible Person
Address: Building 3, The Heights Brooklands
Weybridge, Surrey, England, United Kingdom
Postcode: KT13 0NY

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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 123674. The device is manufactured by SICAT GmbH & Co. KG from Germany, classified as General Medical Device. The authorized representative in the UK is Dentsply IH Limited.

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