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 - DGS Diagnostics A/S

Address:

Audiometer Alle 1

Middelfart

5500

Denmark

Authorised Representative/ UK Responsible Person
Name: Guymark UK Ltd
Address:

Veronica House Old Bush Street

Brierley Hill

West Midlands DY5 1UB

United Kingdom

Code/Term Type

Earphone cushion Earphone cushion Class I

Auditory cranial bone vibrator Auditory cranial bone vibrator Class IIa

Analytical non-scalp cutaneous lead Analytical non-scalp cutaneous lead Class I

Earphone insert Earphone insert Class IIa

Earphone supra-aural Earphone supra-aural Class IIa

Earphone circumaural Earphone circumaural Class IIa

Audiometric/hearing aid tester Audiometric/hearing aid tester Class I

Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Class I

Audiometric ear tip Audiometric ear tip Class I

Analytical scalp electrode reusable Analytical scalp electrode reusable Class I

Analytical scalp electrode reusable Analytical scalp electrode reusable Class I

Analytical scalp electrode reusable Analytical scalp electrode reusable Class I

Analytical scalp electrode reusable Analytical scalp electrode reusable Class IIa

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
Earphone cushion	Earphone cushion	Class I
Auditory cranial bone vibrator	Auditory cranial bone vibrator	Class IIa
Analytical non-scalp cutaneous lead	Analytical non-scalp cutaneous lead	Class I
Earphone insert	Earphone insert	Class IIa
Earphone supra-aural	Earphone supra-aural	Class IIa
Earphone circumaural	Earphone circumaural	Class IIa
Audiometric/hearing aid tester	Audiometric/hearing aid tester	Class I
Analytical non-scalp cutaneous electrode	Analytical non-scalp cutaneous electrode	Class I
Audiometric ear tip	Audiometric ear tip	Class I
Analytical scalp electrode reusable	Analytical scalp electrode reusable	Class I
Analytical scalp electrode reusable	Analytical scalp electrode reusable	Class I
Analytical scalp electrode reusable	Analytical scalp electrode reusable	Class I
Analytical scalp electrode reusable	Analytical scalp electrode reusable	Class IIa