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 - HemoCue AB

Address:

Kuvettgatan 1

Ängelholm

SE-262 71

Sweden

Authorised Representative/ UK Responsible Person
Name: Radiometer Limited
Address:

Manor Court/Manor Royal

Crawley

RH10 9FY

England United Kingdom

Code/Term Type

Haemoglobin analyser IVD point-of-care Haemoglobin analyser IVD point-of-care IVD General

Urine analyser IVD point-of-care Urine analyser IVD point-of-care IVD General

Glucose monitoring system IVD point-of-care Glucose monitoring system IVD point-of-care IVD General

Haematological cell analyser IVD semi-automated Haematological cell analyser IVD semi-automated IVD General

Haemoglobin analyser IVD point-of-care Haemoglobin analyser IVD point-of-care Class A

Haemoglobin analyser IVD point-of-care Haemoglobin analyser IVD point-of-care Class B – Self-testing or Near-patient Testing

Haematological cell analyser IVD semi-automated Haematological cell analyser IVD semi-automated Class A

Glucose monitoring system IVD point-of-care Glucose monitoring system IVD point-of-care Class A

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
Haemoglobin analyser IVD point-of-care	Haemoglobin analyser IVD point-of-care	IVD General
Urine analyser IVD point-of-care	Urine analyser IVD point-of-care	IVD General
Glucose monitoring system IVD point-of-care	Glucose monitoring system IVD point-of-care	IVD General
Haematological cell analyser IVD semi-automated	Haematological cell analyser IVD semi-automated	IVD General
Haemoglobin analyser IVD point-of-care	Haemoglobin analyser IVD point-of-care	Class A
Haemoglobin analyser IVD point-of-care	Haemoglobin analyser IVD point-of-care	Class B – Self-testing or Near-patient Testing
Haematological cell analyser IVD semi-automated	Haematological cell analyser IVD semi-automated	Class A
Glucose monitoring system IVD point-of-care	Glucose monitoring system IVD point-of-care	Class A