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NanoEnTek, Inc.

South Korea·KR-MF-000021903

Last updated September 17, 2026

Information

Country: South Korea
Address: 851-14, Seohae-ro, Hwaseong-si, South Korea
Website: www.nanoentek.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82 010 8785 7859
PRRC Contact: Jason Jeong
EUDAMED SRN: KR-MF-000021903
FDA FEI Number: 3009092698
DUNS Number: 687910463

Catalogue (77)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
FREND Testosterone	FRTE-HB	FDA UDI	Class I	Active
FREND TSH Linearity Kit	FLK-TSH	FDA UDI	Class I	Active
r-Control RBC and PLT	ADRC	FDA UDI	Class II	Active
FREND PSA Plus	FRPS 025	FDA UDI	Class II	Active
FREND Vitamin D Linearity Kit	FLK-VTD	FDA UDI	Class I	Active
FREND PSA Plus Linearity Kit	FLK-PSA	FDA UDI	Class I	Active
FREND Free T4 Linearity Kit	FLK-FT4	FDA UDI	Class I	Active
FREND Testosterone Linearity Kit	FLK-TES	FDA UDI	Class I	Active
FREND Blocking Reagent	FRBR 015	FDA UDI	Class I	Active
FREND hsCRP	FRhCR 025	EUDAMED	IVD General	Active
C-Chip	DHC-B02	EUDAMEDFDA UDI	Class A	Active
Frend™ Covid-19 Sp	FRCOSW 020	EUDAMED	IVD General	Active
Frend Pct	FRPC 025	EUDAMED	IVD General	Active
Adam2 & Cd34k-025	ADAM2 & CD34K-025	EUDAMED	IVD General	Active
FREND Thyroid Duo	FRTD 020	EUDAMED	IVD General	Active
ADAM-rWBC2 & ADAM-rWBC Kit	ADAM-rWBC2 & ADAM-rWBC Kit	EUDAMEDFDA UDI	IVD General	Active
FREND Troponin I	FRTI 025	EUDAMED	IVD General	Active
FREND D-Dimer	FRDD 025	EUDAMED	IVD General	Active
Frend Flu A&B	FRFL 020	EUDAMED	IVD General	Active
BioTracer™ Influenza A&B Rapid Card	11311	EUDAMED	IVD General	Active
ADAM-rWBC2	ADAM-rWBC2	EUDAMEDFDA UDI	Class A	Active
BioTracer™ Influenza A&B Test	11321	EUDAMED	IVD General	Active
FREND Testosterone Test System	K153577	FDA 510(k)	Class I	Active
FREND Vitamin D Test System	K162754	FDA 510(k)	Class II	Active
Frend Psa Plus (reagent Cartridge)	K124056	FDA 510(k)	Class II	Active
FREND™ Free T4 Test System	K152422	FDA 510(k)	Class II	Active
Frend Tsh	FRTS 025	EUDAMEDFDA 510(k)FDA UDI	IVD General	Active
C-Chip	DHC-F0420	EUDAMEDFDA UDI	Class A	Active
FREND Vitamin D	FRVD 020	EUDAMED	IVD General	Active
C-Chip	DHC-B04	EUDAMEDFDA UDI	Class A	Active
ADAM-rWBC Kit	AD1K-050	EUDAMEDFDA UDI	IVD General	Active
ADAM-rWBC Kit	ADHK-050	EUDAMEDFDA UDI	IVD General	Active
Frend Ap	F10AP	EUDAMEDFDA UDI	Class A	Active
COVID-19 Neutralization Ab Control LQ	FIC-CONLQ	EUDAMED	IVD General	Active
ADAM-rWBC & ADAM-rWBC Kit	ADAM-rWBC & ADAM-rWBC Kit	EUDAMEDFDA UDI	IVD General	Active
BioTracer™Dengue IgG/IgM Rapid Card	17112	EUDAMED	IVD General	Active
ADAM-rWBC	ADAM-rWBC	EUDAMEDFDA UDI	Class A	Active
FREND System	F10	EUDAMEDFDA UDI	Class A	Active
S-Chip	DCS-S01	EUDAMED	Class A	Active
En-swer™ COVID-19 RT-PCR Kit	EPCO19100	EUDAMED	IVD General	Active
Fic-Cgsw	FIC-CGSW	EUDAMED	IVD General	Active
C-Chip	DHC-N04	EUDAMEDFDA UDI	Class A	Active
C-Chip	DHC-B0420	EUDAMEDFDA UDI	Class A	Active
COVID-19 SP Control LQ	FIC-COSLQ	EUDAMED	IVD General	Active
FREND™ COVID-19 Neutralization Ab	FRCON 020	EUDAMED	IVD General	Active
Adamii	ADAMII	EUDAMEDFDA UDI	Class A	Active
ADAMII™-CD3/CD4/CD8 Kit	CD348K-025	EUDAMED	IVD General	Active
ADAM-rWBC HT	ADAM-rWBC HT	EUDAMEDFDA UDI	Class A	Active
Frend™ Covid-19 Sp	FRCOS 020	EUDAMED	IVD General	Active
FREND™ COVID-19 IgG/IgM Duo	FRCOD 020	EUDAMED	IVD General	Active

Related Companies

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Medical Technology Promedt Consulting GmbH DE

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