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 - NxStage Medical Inc.

Address:

350 Merrimack Street

Massachusetts

01843

United States

Authorised Representative/ UK Responsible Person
Name: Fresenius Medical Care UK Limited
Address:

Nunn Brook Road Huthwaite

Sutton-in-Ashfield

Nottinghamshire NG17 2HU

England United Kingdom

Code/Term Type

Haemodialysis system institutional/home-use Haemodialysis system institutional/home-use Class IIb

Haemodialysis dialysate solution Haemodialysis dialysate solution 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
Haemodialysis system institutional/home-use	Haemodialysis system institutional/home-use	Class IIb
Haemodialysis dialysate solution	Haemodialysis dialysate solution	Class IIb