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 - AgaMatrix Inc.

Address:

7C Raymond Avenue

Salem

New Hampshire 03079

United States

Authorised Representative/ UK Responsible Person
Name: AgaMatrix Europe Limited
Address:

Harwell Innovation Centre 173 Curie Avenue

Harwell Oxford

DIDCOT

Oxfordshire OX11 0QG

England United Kingdom

Code/Term Type

Blood lancet single-use Blood lancet single-use Class IIa

Manual blood lancing device reusable Manual blood lancing device reusable Class I

Glucose monitoring system IVD home-use Glucose monitoring system IVD home-use IVD Annex II List B

Glucose IVD reagent Glucose IVD reagent IVD Annex II List B

Glucose IVD control Glucose IVD control IVD Annex II List B

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
Blood lancet single-use	Blood lancet single-use	Class IIa
Manual blood lancing device reusable	Manual blood lancing device reusable	Class I
Glucose monitoring system IVD home-use	Glucose monitoring system IVD home-use	IVD Annex II List B
Glucose IVD reagent	Glucose IVD reagent	IVD Annex II List B
Glucose IVD control	Glucose IVD control	IVD Annex II List B