Manufacturer's Devices - i-SENS Inc.
Address:
43 Banpo-daero 28-gil Seocho-gu
Seoul
06646
South Korea
Authorised Representative/ UK Responsible Person
Name: MT Promedt Consulting Ltd
Address:
Beaver House 23-38 Hythe Bridge Street
Oxford
OX1 2EP
England United Kingdom
| Code/Term |
|
Type |
| Manual blood lancing device reusable | Manual blood lancing device reusable | Class I
|
| Glucose/ketone monitoring system IVD home-use | Glucose/ketone monitoring system IVD home-use | IVD Annex II List B
|
| Multiple blood gas/haemoximetry/electrolyte analyte IVD control | Multiple blood gas/haemoximetry/electrolyte analyte IVD control | IVD General
|
| Fluorescent immunoassay/spectrophotometry analyser IVD point-of-care | Fluorescent immunoassay/spectrophotometry analyser IVD point-of-care | IVD General
|
| Glycated haemoglobin (HbA1c) IVD reagent | Glycated haemoglobin (HbA1c) IVD reagent | IVD General
|
| Glycated haemoglobin (HbA1c) IVD control | Glycated haemoglobin (HbA1c) IVD control | IVD General
|
| Albumin/creatinine ratio (ACR) IVD reagent | Albumin/creatinine ratio (ACR) IVD reagent | IVD General
|
| Albumin/creatinine ratio (ACR) IVD control | Albumin/creatinine ratio (ACR) IVD control | IVD General
|
| Multiple blood gas/haemoximetry/electrolyte analyte IVD reagent | Multiple blood gas/haemoximetry/electrolyte analyte IVD reagent | IVD General
|
| Metabolic profile clinical chemistry analyser IVD | Metabolic profile clinical chemistry analyser IVD | IVD General
|
| Glucose monitoring system IVD home-use | Glucose monitoring system IVD home-use | IVD Annex II List B
|