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SHENZHEN YHLO BIOTECH CO., LTD.

China·CN-MF-000001137

Last updated September 17, 2026

Information

Country: China
Address: Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District,Shenzhen,Guangdong, 518116, China, SHENZHEN,Guangdong, China
Website: www.szyhlo.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-755-26473359
PRRC Contact: Chungen Qian
EUDAMED SRN: CN-MF-000001137
FDA FEI Number: 3017019647
DUNS Number: —

Catalogue (423)

Page 6 of 9

Device	Model / Reference	Registries	Class	Status
UNION Immune Analyzer	U6103	EUDAMED	Class A	Active
iFlash-dsDNA IgG	C89015G	EUDAMED	Class B	Active
iFlash-NT-proBNP	C89244-S	EUDAMED	Class C	Active
LIA-AAs Screen-Profile	T-L89407G1	EUDAMED	IVD General	Active
Sample Diluent	C89914	EUDAMEDFDA UDI	Class A	Active
ANA Control	CC830	EUDAMED	IVD General	Active
iFlash 9000 CLIA Analyzer	FG0076	EUDAMED	Class A	Active
iFlash-Renin	C86284	EUDAMED	Class B	Active
iFlash-Calcitonin	C86291	EUDAMED	Class C	Active
HSV-1 IgM Control	CC838	EUDAMED	IVD General	Active
Reaction vessel	C6100	EUDAMEDFDA UDI	Class A	Active
Trigger Solution (1×)	C89958	EUDAMEDFDA UDI	Class A	Active
Immunofluorescence Reader	F6101	EUDAMED	Class A	Active
iFlash-DGP IgA	C86073A	EUDAMED	Class B	Active
Rheumatoid Arthritis Multi Control	CC833	EUDAMED	IVD General	Active
iFlash-Gastrin-17	C86055	EUDAMED	Class B	Active
EB VCA IgA Control	CC855	EUDAMED	IVD General	Active
iFlash-Cleaning Solution	C80003	EUDAMEDFDA UDI	Class A	Active
LIA-Vasculitis-Profile	L89403G2-2	EUDAMED	IVD General	Active
iFlash-Chlamydia pn. IgG	C88013G	EUDAMED	Class C	Active
Sample Diluent	C89912	EUDAMEDFDA UDI	Class A	Active
Sample Diluent	C89919-1	EUDAMEDFDA UDI	Class A	Active
Sample Diluent	C89917	EUDAMEDFDA UDI	Class A	Active
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)	K223690	FDA 510(k)	Class II	Active
EB NA IgA Control	CC852	EUDAMED	IVD General	Active
iFlash-D-dimer	C86238	EUDAMED	Class C	Active
iFlash-CRP	C86313	EUDAMED	Class C	Active
iFlash-Androstenedione	C86062	EUDAMEDFDA UDI	Class B	Active
iFlash-Androstenedione	C86062-S	EUDAMED	Class B	Active
iFlash-HSV-2 IgM	C88039M	EUDAMED	Class C	Active
iFlash-ICA	C89050G	EUDAMED	Class B	Active
β2-Glycoprotein I IgG Control	CC824	EUDAMED	IVD General	Active
Sample Diluent	C89915	EUDAMEDFDA UDI	Class A	Active
Cardiolipin IgG Control	CC821	EUDAMED	IVD General	Active
ZnT8A Control	CC213	EUDAMED	IVD General	Active
SMA IgG Control	CC367	EUDAMED	Class B	Active
dsDNA IgG Control	CC831	EUDAMED	IVD General	Active
EB EA IgM Control	CC856	EUDAMED	IVD General	Active
Pre-Trigger Solution (1x)	C89959	EUDAMEDFDA UDI	Class A	Active
iFlash-CenpB IgG	C86078G	EUDAMED	Class B	Active
iFlash-SMA IgG	C88046G	EUDAMED	Class B	Active
Trigger Solution (1×)	C89948	EUDAMEDFDA UDI	Class A	Active
iFlash-Chlamydia pn. IgM	C88014M	EUDAMED	Class C	Active
PR3 IgG Control	CC835	EUDAMED	IVD General	Active
MPO IgG Control	CC834	EUDAMED	IVD General	Active
iFlash-Free PSA	C86001	EUDAMED	Class C	Active
HA Control	CC278	EUDAMED	IVD General	Active
iFlash-Rib-P0 IgG	C86077G	EUDAMED	Class B	Active
iFlash-PM-Scl IgG	C86081G	EUDAMED	Class B	Active
M. Pneumoniae IgG Control	CC847	EUDAMED	IVD General	Active

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FDA Establishments (1)

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

Shenzhen YHLO Biotech Co., Ltd. US