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URIT Medical Electronic Co., Ltd.: FDA-registered device maker in Guilin Guangxi, China, 2 510(k) clearances

Name: URIT Medical Electronic Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

URIT Medical Electronic Co., Ltd. is registered with the FDA (registration 3010891909) in Guilin Guangxi, China. It lists 28 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 26, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010891909
Address: No. D-07, Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P.R.China, Guilin Guangxi, China, 541004
Owner or operator: URIT Medical Electronic Co., Ltd (10055160)
Roles: Contract manufacturer, Manufacturer
First device listed: June 14, 2017
Registered through: 2026
Brand names listed: DxU 11 Urinalysis Control, DxU 11FA, DxU 12FA DxU Urine Chemistry Strips, DxU 14 Urinalysis Control, DxU 1800 System Bridge, DxU 1800c Fully-Automated Urine Chemistry Analyzer, DxU Color Control, DxU Detergent Concentrated, DxU Detergent Ready to Use and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	JMA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Acid, Uric, Uricase (Oxygen Rate)	JHC	1	Manufacturer	accessdata.fda.gov
Automated Urinalysis System	KQO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Blood, Occult, Colorimetric, In Urine	JIO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Colorimetric Method, Triglycerides	JGY	1	Manufacturer	accessdata.fda.gov
Control, Hemoglobin	GGM	2	Manufacturer	accessdata.fda.gov
Detergent	JCB	1	Manufacturer	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Manufacturer	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
Hydrazone Colorimetry, Alt/Sgpt	CKD	1	Manufacturer	accessdata.fda.gov
Hydrazone Colorimetry, Ast/Sgot	CIS	2	Manufacturer	accessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Manufacturer	accessdata.fda.gov
Magnifier, Hand-Held, Low-Vision	HJF	1	Manufacturer	accessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Refractometer For Clinical Use	JRE	1	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer	accessdata.fda.gov
Solution, Copper Sulfate For Specific Gravity Determinations	KSL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Manufacturer	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Urinalysis Controls (Assayed And Unassayed)	JJW	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 26, 2024	K232317	UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips	JIO	Substantially Equivalent	Urit Medical Electronic Co., Ltd.	accessdata.fda.gov
September 11, 2009	K082811	URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS	JIO	Substantially Equivalent	Urit Medical Electronic Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.