Eu Ivdd Eu Ivd Self Testing On The Market 🇰🇷 South Korea

CareBuddy

CareforU.Co.Ltd · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1

Basic Information

Primary DI
D-8800210900006UK
Basic UDI-DI Code
B-8800210900006UK
Reference
CGSB02
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd Self Testing
Status
On The Market
Manufacturer
CareforU.Co.Ltd

Additional Description

Care Blood Glucose Test Strips work with the Care Blood Glucose Meters to quantitatively measure glucose in whole blood . The Care Blood Glucose Monitoring Systems is for self-testing outside the body (in vitro diagnostic use). The Care Blood Glucose Monitoring Systems should not be used for the diagnosis of diabetes or for testing newborns . Glucose in blood samples reacts with the chemical in the test strip to produce a small electrical current. The CareBuddy Brand of Blood Glucose Meters detect the electrical current which reflects the amount of glucose in the blood sample

CND Nomenclature Codes

Code Description
W0101060101 GLUCOSE TEST STRIPS

Certificates

Type Number
IVDD Annex III Section 6 1434-IVDD-178/2022

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