Urit Medical Electronic Co., Ltd.
Manufacturer and brand owner in Guilin, Guangxi, China. 28 device types, 37 products catalogued, 2 clearances.
Urit Medical Electronic Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Detergent, Control, Hemoglobin and 26 other device types. 37 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
28device types registered with the FDA
37products catalogued under its own name
2510(k) clearances
Registration
| Registered name | URIT Medical Electronic Co., Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010891909 |
| FEI number | 3010891909 |
| DUNS | 653742429 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 桂林优利特医疗电子有限公司 |
|---|---|
| Unified social credit code | 9145030075651305XT |
| Source | NMPA UDI database |
Location
| City | Guilin |
|---|---|
| Province | Guangxi |
| Address | No. D-07, Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P.R.China |
| Postal code | 541004 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | FG-01 Medical Goggles | 2020 | 439 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | Class 1 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 10 |
| Acid, Uric, Uricase (Oxygen Rate) | Class 1 | URIT U10 Uric Acid Test Strip, URIT U10 Uric Acid Test Strip, PA 11 Uric Acid Test Strip, PA 16 Uric Acid Test Strip, PA-11/PA-11A Uric Acid Meter and Strips, PA-16/16A Uric Acid Meter and Strips, URIT-10 Uric Acid Meter | 2022 | 1 |
| Automated Urinalysis System | Class 1 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 16 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Class 1 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 12 |
| Blood, Occult, Colorimetric, In Urine | Class 2 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 5 |
| Colorimetric Method, Triglycerides | Class 1 | PFS-30 /PFS-30A / PFS-30B Blood Lipid Analyzer and strips, PFS 30 Blood Lipid Test Strip | 2023 | 5 |
| Control, Hemoglobin | Class 2 | 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, | 2023 | 2 |
| Detergent | Class 1 | DxU Maintenance Agent, URIT D 22 Detergent for Automatic Urine Analyzer, URIT D 21 Detergent for Automatic Urine Analyzer, URIT D 21N Detergent for Automatic Urine Analyzer,, DxU Detergent Ready to Use, DxU Detergent Concentrated | 2024 | 5 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class 1 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 14 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Class 1 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 11 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class 1 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 16 |
| Enzymatic Esterase–Oxidase, Cholesterol | Class 1 | PFS-30 /PFS-30A / PFS-30B Blood Lipid Analyzer, PFS 30 Blood Lipid Test Strip | 2023 | 9 |
| Enzymatic Method, Creatinine | Class 2 | 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 | 2024 | 4 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | DxU 1800 System Bridge | 2026 | 72 |
| Hydrazone Colorimetry, Alt/Sgpt | Class 1 | PL 92/PL 92A/PL 92B Alanine Aminotransferase Test Strip | 2026 | 4 |
| Hydrazone Colorimetry, Ast/Sgot | Class 2 | PS 92/PS 92A/PS 92B Aspartate Aminotransferase Test Strip | 2026 | 1 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Class 1 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 14 |
| Ldl & Vldl Precipitation, Hdl | Class 1 | PFS-30 /PFS-30A / PFS-30B Blood Lipid Analyzer and strips, PFS 30 Blood Lipid Test Strip | 2023 | 3 |
| Magnifier, Hand-Held, Low-Vision | Class 1 | EX-06 Magnifier | 2025 | 22 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Class 2 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 5 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | Class 1 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 17 |
| Refractometer For Clinical Use | Class 1 | 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 | 2024 | 8 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | FG-01 Medical Goggles | 2020 | 384 |
| Solution, Copper Sulfate For Specific Gravity Determinations | Class 1 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 5 more | 2017 | 5 |
| System, Test, Low Density, Lipoprotein | Class 1 | PFS-30 /PFS-30A / PFS-30B Blood Lipid Analyzer and strips, PFS 30 Blood Lipid Test Strip | 2023 | 3 |
| Test, Urine Leukocyte | Class 1 | HTI CL-500 Urine Analyzer, Uritest 11G Urine Reagent Strips, UrineRS-10, Urine Strips, UrineRS-11, Urine Strips, UrineRS-13, Urine Strips, HTI CL-50 Plus Urine Analyzer and 8 more | 2017 | 16 |
| Urinalysis Controls (Assayed And Unassayed) | Class 1 | DxU Turbidity Calibrator, DxU Color Control, DxU SG Control, DxU Multiple Control for SG, DxU Turbidity Control, DxU 14 Urinalysis Control and 6 more | 2024 | 3 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232317 | 2024-04-26 | JIO | Traditional | This company |
| K082811 | 2009-09-11 | JIO | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1984 |
|---|---|
| Employees | 700-2000 |
| Factory area | 60000 |
| Main products | Urine analyzers, Blood cell analysis equipment, Biochemical immunology reagents |
| Certifications | National high-tech enterprise, National engineering laboratory for immunodiagnostic reagents |
| Export markets | 180+ countries |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Guilin Yikeshi Medical Device Co Ltd | 28 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | 25 |
| Guilin Kevin Peter Technology Co., Ltd. | 13 |
| Guilin Refine Medical Instrument Co., Ltd. | 7 |
| Guilin Veirun Medical Technology Co., Ltd. | 4 |
| Guilin HBM Health Protections, Inc. | 2 |
| Guilin Huada Biotechnology Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.