Is this your brand? Sign in to claim ownership.

Sd Biosensor

South Korea·KR-MF-000009168

Last updated May 23, 2026

Information

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
SD GlucoNavii Blood Glucose Monitoring System	01GM11	FDA UDI	Class II	Active
SD GlucoNavii Blood Glucose Monitoring System	01GC110	FDA UDI	Class II	Active
SD GlucoNavii Blood Glucose Test Strip	01GS11C	FDA UDI	Class II	Active
STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile	02LS10C	FDA UDI	Class I	Active
STANDARD™ LipidoCare Analyzer	02LA20G	FDA UDI	Class I	Active
STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile	02LS10C	FDA UDI	Class I	Active
STANDARD™ LipidoCare Analyzer	02LA10G	FDA UDI	Class I	Active
SD GlucoNavii Blood Glucose Test Strip	01GS11	FDA UDI	Class II	Active
SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set	K140827	FDA 510(k)	Class II	Active
SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System	K151265	FDA 510(k)	Class II	Active
SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System	K160282	FDA 510(k)	Class II	Active
Sd Gluconavii Mentor Nfc Multi Blood Glucose Monitoring System, And Sd Gluconavii Mentor Nfc Blood Glucose Monitoring System	K132929	FDA 510(k)	Class II	Active
SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System	K153201	FDA 510(k)	Class II	Active
Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring System	K123517	FDA 510(k)	Class II	Active

No authorised representatives on record.

Not available yet.

Not available yet.

Not available yet.

Establishments registered with the FDA under this company group, matched by name.