Tracheostomy tube speech valve - UK MHRA Medical Device Registration
Tracheostomy tube speech valve is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 199180. The device is manufactured by Primed Halberstadt Medizintechnik GmbH from Germany, classified as General Medical Device. The authorized representative in the UK is Advena Ltd.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Device Type
General Medical Device
Devices
Tracheostomy tube speech valve
Type
Class IIa
Date Registered
Nov 26, 2024
Last Updated
Sep 25, 2024
Address
Straรe des 20. Juli 1
Halberstadt, Germany
Created Date
Aug 25, 2021
Name
Advena LtdRelationship Type
Address
Pure Offices Plato Close
Warwick, England, United Kingdom
Postcode: CV34 6WE
Wireless patient monitor/sensor reporting software, professional-only
Type: General Medical Device
Manufacturer: GE Medical Systems Information Technologies, Inc.
Bedside physiologic monitoring software
Type: General Medical Device
Manufacturer: ZOLL Medical Corporation
Physiologic monitoring system alarm
Type: General Medical Device
Manufacturer: GE Medical Systems Information Technologies, Inc.
Wireless patient monitor/sensor reporting software, professional-only
Type: General Medical Device
Manufacturer: GE Medical Systems Information Technologies, Inc.
Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Stationary gamma camera system
Type: General Medical Device
Manufacturer: GE Medical Systems Israel Functional Imaging
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Orthopaedic implant aiming/guiding block, reusable
Type: General Medical Device
Manufacturer: Orthofix S.r.l.
Bedside information system application software
Type: General Medical Device
Manufacturer: GE Medical Systems Information Technologies, Inc.
Hypnotherapy virtual reality software
Type: General Medical Device
Manufacturer: Oncomfort SA
Laryngectomy tube
Type: General Medical Device
Registered: Mar 25, 2025
Tracheostomy tube dressing
Type: General Medical Device
Registered: Dec 19, 2024
Thoracic suction collection container
Type: General Medical Device
Registered: Dec 19, 2024
Tracheostoma protector, reusable
Type: General Medical Device
Registered: Dec 19, 2024
Closed-wound/centesis drainage receptacle
Type: General Medical Device
Registered: Dec 19, 2024
Tracheostomy tube neck holder, reusable
Type: General Medical Device
Registered: Dec 19, 2024
Closed-wound drain, non-bioabsorbable
Type: General Medical Device
Registered: Dec 19, 2024
Tracheostomy tube dressing
Type: General Medical Device
Registered: Dec 19, 2024
Tracheostomy tube dressing
Type: General Medical Device
Registered: Dec 19, 2024
Thoracic suction collection container
Type: General Medical Device
Registered: Dec 19, 2024
Portable/mobile rechargeable battery pack
Type: General Medical Device
Manufacturer: Total Healthcare Innovation GmbH
Surgical gown, single-use
Type: General Medical Device
Manufacturer: Total Healthcare Innovation GmbH
Interproximal reduction kit
Type: General Medical Device
Manufacturer: TP Orthodontics, Inc.
Orthodontic archwire
Type: General Medical Device
Manufacturer: TP Orthodontics, Inc.
Orthodontic archwire/bracket ligature
Type: General Medical Device
Manufacturer: TP Orthodontics, Inc.
Orthodontic bracket, metal
Type: General Medical Device
Manufacturer: TP Orthodontics, Inc.
Orthodontic lock
Type: General Medical Device
Manufacturer: TP Orthodontics, Inc.
Orthodontic retainer
Type: General Medical Device
Manufacturer: TP Orthodontics, Inc.
Orthodontic wire
Type: General Medical Device
Manufacturer: TP Orthodontics, Inc.
Battery box
Type: General Medical Device
Manufacturer: Total Healthcare Innovation GmbH

