Manufacturer's Devices - i-SENS Inc.

Address:




43 Banpo-daero 28-gil Seocho-gu



Seoul

06646

South Korea

Serilization:


Authorised Representative
Name: MT Promedt Consulting Ltd
Address:

Beaver House 23-38 Hythe Bridge Street



Oxford

OX1 2EP

England United Kingdom




Code/Term Type
Glucose monitoring system IVD, home-useIVD Annex II List B
Glucose/ketone monitoring system IVD, home-useIVD Annex II List B
Manual blood lancing device, reusableClass I
Multiple blood gas/haemoximetry/electrolyte analyte IVD, controlIVD General
Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-careIVD General
Glycated haemoglobin (HbA1c) IVD, reagentIVD General
Glycated haemoglobin (HbA1c) IVD, controlIVD General
Albumin/creatinine ratio (ACR) IVD, reagentIVD General
Albumin/creatinine ratio (ACR) IVD, controlIVD General
Metabolic profile clinical chemistry analyser IVD, portable, automatedIVD General
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagentIVD General