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DFI Co.,Ltd.

South Korea·KR-MF-000015786

Last updated June 8, 2026

Information

Country: South Korea
Address: 388-25, Gomo-ro, Jillye-myeon, Gimhae-si, South Korea
Website: dficare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: YONGAE PARK
EUDAMED SRN: KR-MF-000015786
FDA FEI Number: —
DUNS Number: —

Catalogue (89)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Newfoundland Cholesterol Test	6450	FDA UDI	Class I	Active
ONE+Step Uric Acid	31H7P	FDA UDI	Class I	Active
Cybow 11	0A94	FDA UDI	Class I	Active
One+Step Uric Acid	31H0P	FDA UDI	Class I	Active
One+Step pH	8174	FDA UDI	Class I	Active
Qtest K	0124	EUDAMEDFDA UDI	Class I	Active
Just Fitter pH Test Strips	31KC	FDA UDI	Class I	Active
ONE+Step Uric Acid	31H1	FDA UDI	Class I	Active
One+Step Protein	8194	FDA UDI	Class I	Active
One+Step Salive & Urine pH	31I4	FDA UDI	Class I	Active
Cybow 10	0004	FDA UDI	Class II	Active
QUCARE®Self Total Cholesterol	6400P	FDA UDI	N/A	Active
Qtest™ 11	0994	FDA UDI	Class I	Active
One+Step Ketone	81A4	FDA UDI	Class I	Active
One+Step 10A	30D4	FDA UDI	Class I	Active
Cybow P	0143	EUDAMEDFDA UDI	Class I	Active
Yodoc 10	0024	FDA UDI	Class II	Active
QUCARE®Self Total Cholesterol	6407	EUDAMEDFDA UDI	N/A	Active
ONE+Step Uric Acid	31H7	FDA UDI	Class I	Active
Trueline R-300	TA5200	EUDAMED	Class A	Active
Trueline R-600s	TA5300	EUDAMED	Class A	Active
DUS R-50S (Urine Chemistry system)	K171521	FDA 510(k)	Class II	Active
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips	K181024	EUDAMEDFDA 510(k)	Class II	Active
Cybow Reader, Models 300 & 720	K102188	FDA 510(k)	Class I	Active
Cybow 11 Series Reagent Strips For Urinalysis	K052525	EUDAMEDFDA 510(k)	Class II	Active
Cybow R-600s	5300	EUDAMED	Class A	Active
Uritop R-50s	FA5640	EUDAMED	Class A	Active
Dus R-600s	5360	EUDAMED	Class A	Active
ComboStik R-50S	5640	EUDAMED	Class A	Active
ComboStik R-600S	5340	EUDAMED	Class A	Active
Dus R-60s	5A60	EUDAMED	Class A	Active
ComboStik R-300S	5240	EUDAMED	Class A	Active
URIcrom	DB5600	EUDAMED	Class A	Active
Dus R-300	5260	EUDAMED	Class A	Active
Cybow R-50s	5600	EUDAMED	Class A	Active
Cybow R-60s	5A00	EUDAMED	Class A	Active
U-AQ Handy	KC5660	EUDAMED	Class A	Active
ComboStik R-60S	5A40	EUDAMED	Class A	Active
U-AQ Smart	KB5260	EUDAMED	Class A	Active

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