Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010891909

FEI Number

3010891909

Entity Name

URIT Medical Electronic Co., Ltd.

City/State/Country

Guilin Guangxi, CN

Establishment Address

No. D-07, Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P.R.China, Guilin Guangxi 541004, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

URIT Medical Electronic Co., Ltd (Owner Number: 10055160)

Owner / Operator Contact Address

206 Williams St, Wrentham, MA 02093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PFS-30 /PFS-30A / PFS-30B Blood Lipid Analyzer and strips, PFS 30 Blood Lipid Test Strip PH-01 / PH-01A / PH-01B Hemoglobin Meter and strips, URIT-12 Hemoglobin Meter PH 01 Hemoglobin Test Strip, H12 Hemoglobin Test Strip, HQ-A/HQ 02/HQ 03 Hemoglobin Control Solution, PFS-30 /PFS-30A / PFS-30B Blood Lipid Analyzer and strips, PFS 30 Blood Lipid Test Strip FG-01 Medical Goggles EX-06 Magnifier PS 92/PS 92A/PS 92B Aspartate Aminotransferase Test Strip UC-1800 Automatic Urine Analyzer; URIT 11FA, URIT 12FA Urine Reagent Strips DxU 11FA, DxU 12FA DxU Urine Chemistry Strips DxU 1800c Fully-Automated Urine Chemistry Analyzer DxU Detergent Concentrated URIT D 21 Detergent for Automatic Urine Analyzer, URIT D 21N Detergent for Automatic Urine Analyzer, URIT D 22 Detergent for Automatic Urine Analyzer DxU Maintenance Agent DxU Detergent Ready to Use PFS-30 /PFS-30A / PFS-30B Blood Lipid Analyzer, PFS 30 Blood Lipid Test Strip PFS-30 /PFS-30A / PFS-30B Blood Lipid Analyzer and strips, PFS 30 Blood Lipid Test Strip DxU 1800 System Bridge PL 92/PL 92A/PL 92B Alanine Aminotransferase Test Strip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2023-04-26
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2023-04-26
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2023-04-26
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-14
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5540	2025-08-26
CIS	Hydrazone Colorimetry, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2026-02-09
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2024-05-21
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2024-05-21
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2024-05-21
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2024-05-21
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2024-05-21
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2024-05-21
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2024-05-21
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2024-05-21
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2024-05-21
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2024-05-21
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2024-05-21
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2024-05-21
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2024-05-21
JCB	Detergent	Pathology	Class 1	864.4010	2024-05-21
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2023-04-26
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2023-04-26
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2026-06-18
CKD	Hydrazone Colorimetry, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2026-02-09

Official Correspondent

Gary Titov

US Agent Details

Gary Titov Email: garyt@htmed.com Phone: (617) 3889598

Related Public Records

Same Entity

URIT Medical Electronic Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K012065	Wiener Laboratories Saic	WIENER LAB. CREATININA CINETICA AA	2001-10-10
K183555	Instrumentation Laboratory CO	GEM Premier ChemSTAT	2019-02-16
K090330	Siemens Healthcare Diagnostics, Inc.	DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270	2009-05-22
K212223	Siemens Healthcare Diagnostics, Inc.	Atellica CH Enzymatic Creatinine_3 (ECre3)	2021-11-24
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2009	Roche Diagnostics Corp.	1	Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.
Z-0008-2009	Roche Diagnostics Corp.	2	Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of creatine in serum, urine and plasma.
Z-0081-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010891909. Last updated year: 2026. Please use registration number 3010891909 when referencing this establishment in official correspondence.