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Sd Biosensor

South Korea·KR-MF-000009168

Last updated May 23, 2026

Information

Country: South Korea
Address: 1556beon-gil, Deogyeong-daero, Gyeonggi-do, Suwon-si, South Korea
Website: www.sdbiosensor.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82 80-970-9700
PRRC Contact: KyuHee Lim
EUDAMED SRN: KR-MF-000009168
FDA FEI Number: —
DUNS Number: —

Catalogue (64)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
Pic Diabetes Management	99DMS30	EUDAMED	Class A	Active
STANDARD™ d-BLOCK Incubator	12INC10	EUDAMED	Class A	Active
STANDARD™ Q COVID-19 Ag Test 2.0	Q-NCOV-07G/ 09COV175D	EUDAMED	Class B	Active
STANDARD™ M10 Stool Pretreatment kit	11PRT20A	EUDAMED	Class A	Active
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ i TSH	16TSH10D	EUDAMED	Class B	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ M10 STI Sample Pretreatment Kit	M10-STIP-01	EUDAMED	Class A	Active
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
STANDARD™ i TSH	16TSH10F	EUDAMED	Class B	Active
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
STANDARD™ M10 C. difficile BT	11CDC20A	EUDAMED	Class B	Active
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
STANDARD™ F Calibration Kit	10CAL10	EUDAMED	Class A	Active
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ i2000	16IA200	EUDAMED	Class A	Active
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
STANDARD™ i1000	16IA100	EUDAMED	Class A	Active
STANDARD™ M10 Console	M10-01C/11M1011	EUDAMED	Class A	Active
STANDARD™ F200 Analyzer	10FA20	EUDAMED	Class A	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ d-BLOCK Incubator	12INC10	EUDAMED	Class A	Active
STANDARD™ i Cleanser	16CL10	EUDAMED	Class A	Active
STANDARD™ M10 Calibration Kit	M10-CAL-01/11CAL10H	EUDAMED	Class A	Active
STANDARD™ LMS (Lipid Management Software)	02LMS10	EUDAMED	Class A	Active
STANDARD™ i Wash buffer	16WB10	EUDAMED	Class A	Active
Standard™ M10 Mrsa/Sa	11MSS10A	EUDAMED	Class C	Active
STANDARD™ i TSH	16TSH10Q	EUDAMED	Class B	Active
STANDARD™ F2400 Analyzer	10FA24	EUDAMED	Class A	Active
STANDARD™ DMS (Diabetes Management Software)	01DMS10	EUDAMED	Class A	Active
STANDARD™ i pre-Trigger	16PTR10	EUDAMED	Class A	Active
CURO L7 Lipid Test Strip - Lipid Profile	99LS10-2	FDA UDI	Class I	Active
STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile	02LS10B	FDA UDI	Class I	Active
SD Glucose Control Solution	01GCS10	FDA UDI	Class II	Active
STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile	02LS10B	FDA UDI	Class I	Active
CURO L7 Analyzer	99LA10G-2	FDA UDI	Class II	Active
SD GlucoNavii Blood Glucose Monitoring System	01GC111	FDA UDI	Class II	Active

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FDA Establishments (1)

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

SD Biosensor, Inc. Cheongju-si Chungbuk · KR FEI 3008959428