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NanoEnTek, Inc.

South Korea·KR-MF-000021903

Last updated September 17, 2026

Information

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
FREND™ COVID-19 Ag+FLU A&B	FRCGFL 020	EUDAMED	IVD General	Active
C-Chip	DHC-N01	EUDAMEDFDA UDI	Class A	Active
FREND Total T3	FRTT3 020	EUDAMED	IVD General	Active
BioTracer™ Dengue Combo Rapid Card	17311	EUDAMED	IVD General	Active
FREND Testosterone	FRTEAP 020	EUDAMEDFDA UDI	IVD General	Active
BioTracer™ Dengue NS1 Ag Rapid Card	17212	EUDAMED	IVD General	Active
Frend 2.0	F20	EUDAMED	Class A	Active
FREND Total T3	FRTT3AP 020	EUDAMED	IVD General	Active
Frend Bnp	FRBN 025	EUDAMED	IVD General	Active
COVID-19 total Ab Control LQ	FIC-COALQ	EUDAMEDFDA UDI	IVD General	Active
FREND PSA Plus	FRPS 025	EUDAMEDFDA 510(k)FDA UDI	IVD Annex II List B	Active
FREND Free T4	FRT4AP 020	EUDAMEDFDA UDI	IVD General	Active
ImmunoAssay Contorl FD Level 1&2	FIC-IAFD	EUDAMED	IVD General	Active
FREND™ COVID-19 total Ab	FRCOA 020	EUDAMEDFDA UDI	IVD General	Active
C-Chip	DHC-F01	EUDAMEDFDA UDI	Class A	Active
ADAMII-CD34 Kit	CD34K-025	EUDAMEDFDA UDI	IVD General	Active
FREND Cardiac Triple	FRCT 025	EUDAMED	IVD General	Active
C-Chip	DHC-F04	EUDAMEDFDA UDI	Class A	Active
C-Chip	DHC-N0420	EUDAMEDFDA UDI	Class A	Active
FREND COVID-19 Ag	FRCOG-J 020P	EUDAMED	IVD General	Active
COVID-19 IgG/IgM Control LQ	FIC-COLQ	EUDAMED	IVD General	Active
Cardiac Marker Control FD Level 1&2	FIC-CMFD	EUDAMED	IVD General	Active
C-Chip	DHC-B01	EUDAMEDFDA UDI	Class A	Active
C-Chip	DHC-M01	EUDAMEDFDA UDI	Class A	Active
FREND Thyroid Duo	FRTDAP 020	EUDAMED	IVD General	Active
Inflammation Control FD Level 1&2	FIC-IFFD	EUDAMED	IVD General	Active
FREND Vitamin D	FRVDAP 020	EUDAMEDFDA UDI	IVD General	Active

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