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 - NIKKISO CO. LTD.

Address:

20-3 Ebisu 4-Chome Shibuya-ku

Tokyo

150-6022

Japan

Authorised Representative/ UK Responsible Person
Name: FREYR LIFE SCIENCES LTD
Address:

9 Greyfriars Road

Reading

Berkshire RG1 1NU

England United Kingdom

Code/Term Type

Haemodialysis system dialysate pyrogen filter Haemodialysis system dialysate pyrogen filter Class IIa

Haemodialysis system dialysate delivery unit Haemodialysis system dialysate delivery unit Class IIb

Hollow-fibre haemodialysis dialyser single-use Hollow-fibre haemodialysis dialyser single-use Class IIb

Haemodialysis blood tubing set single-use Haemodialysis blood tubing set single-use Class IIa

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 dialysate pyrogen filter	Haemodialysis system dialysate pyrogen filter	Class IIa
Haemodialysis system dialysate delivery unit	Haemodialysis system dialysate delivery unit	Class IIb
Hollow-fibre haemodialysis dialyser single-use	Hollow-fibre haemodialysis dialyser single-use	Class IIb
Haemodialysis blood tubing set single-use	Haemodialysis blood tubing set single-use	Class IIa