Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Atos Medical AB

Address:

Atos Medical AB Kraftgatan No.8

Horby

24235

Sweden

Authorised Representative/ UK Responsible Person
Name: Atos Medical UK Ltd
Address:

Atos Medical UK Ltd Tottle Road

Cartwright House

Nottingham

Nottinghamshire NG2 1RT

England United Kingdom

Code/Term Type

Tracheoesophageal fistula dilator Tracheoesophageal fistula dilator Class IIa

Tracheoesophageal speech valve guidewire Tracheoesophageal speech valve guidewire Class IIa

Tracheoesophageal speech valve occluder non-valved Tracheoesophageal speech valve occluder non-valved Class IIa

Tracheoesophageal speech valve indwelling Tracheoesophageal speech valve indwelling Class IIb

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Tracheoesophageal fistula dilator	Tracheoesophageal fistula dilator	Class IIa
Tracheoesophageal speech valve guidewire	Tracheoesophageal speech valve guidewire	Class IIa
Tracheoesophageal speech valve occluder non-valved	Tracheoesophageal speech valve occluder non-valved	Class IIa
Tracheoesophageal speech valve indwelling	Tracheoesophageal speech valve indwelling	Class IIb