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 - Bosch Healthcare Solutions GmbH

Address:

Stuttgarter Straße 130

Waiblingen

71332

Germany

Authorised Representative/ UK Responsible Person
Name: Randox Laboratories Limited
Address:

Ardmore 55 The Diamond Road

Crumlin

County Antrim BT29 4QY

Northern Ireland United Kingdom

Code/Term Type

Electrochemical breath analysis system IVD Electrochemical breath analysis system IVD IVD General

Electrochemical breath analyser filter/mouthpiece IVD Electrochemical breath analyser filter/mouthpiece IVD IVD General

Electrochemical breath analyser filter/mouthpiece IVD Electrochemical breath analyser filter/mouthpiece IVD IVD Devices for Self-Testing

Electrochemical breath analyser IVD home-use Electrochemical breath analyser IVD home-use IVD Devices for Self-Testing

Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT) Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT) IVD Annex II List B

Thermal cycler nucleic acid amplification analyser IVD laboratory Thermal cycler nucleic acid amplification analyser IVD laboratory IVD General

SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT) IVD General

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
Electrochemical breath analysis system IVD	Electrochemical breath analysis system IVD	IVD General
Electrochemical breath analyser filter/mouthpiece IVD	Electrochemical breath analyser filter/mouthpiece IVD	IVD General
Electrochemical breath analyser filter/mouthpiece IVD	Electrochemical breath analyser filter/mouthpiece IVD	IVD Devices for Self-Testing
Electrochemical breath analyser IVD home-use	Electrochemical breath analyser IVD home-use	IVD Devices for Self-Testing
Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT)	Chlamydia trachomatis nucleic acid IVD kit nucleic acid technique (NAT)	IVD Annex II List B
Thermal cycler nucleic acid amplification analyser IVD laboratory	Thermal cycler nucleic acid amplification analyser IVD laboratory	IVD General
SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)	SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)	IVD General