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 - Bittium Biosignals Ltd

Address:

Pioneerinkatu 6 Pioneerinkatu 20

Kuopio

70800

Finland

Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge

CB24 9BZ

England United Kingdom

Code/Term Type

Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Class IIa

Cardiac electrophysiology application software Cardiac electrophysiology application software Class IIa

Electrocardiographic electrode single-use Electrocardiographic electrode single-use Class I

Analytical scalp electrode single-use Analytical scalp electrode single-use Class I

Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Class IIa

Electroencephalographic monitoring system Electroencephalographic monitoring system 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
Telemetric electrocardiographic ambulatory recorder	Telemetric electrocardiographic ambulatory recorder	Class IIa
Cardiac electrophysiology application software	Cardiac electrophysiology application software	Class IIa
Electrocardiographic electrode single-use	Electrocardiographic electrode single-use	Class I
Analytical scalp electrode single-use	Analytical scalp electrode single-use	Class I
Electroencephalographic ambulatory recorder	Electroencephalographic ambulatory recorder	Class IIa
Electroencephalographic monitoring system	Electroencephalographic monitoring system	Class IIb