FDA Registration
Active
🇨🇳 China
URIT Medical Electronic Co., Ltd.
Reg #: 3010891909
·
FEI: 3010891909
·
Expires 2026
Products
28
Proprietary Names
44
Establishment Types
2
Classifications
28
Registration Details
- Registration Name
- URIT Medical Electronic Co., Ltd.
- Registration Number
- 3010891909
- FEI Number
- 3010891909
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. D-07, Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P.R.China
- City
- Guilin Guangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K232317
Owner / Operator
- Firm Name
- URIT Medical Electronic Co., Ltd
- Operator Number
- 10055160
- Address
- 206 Williams St
- City
- Wrentham
- State
- MA
- Postal Code
- 02093
- Country
- US
- Correspondent
- Gary Titov
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2023-04-26 |
| Control, Hemoglobin | GGM | Class 2 | Hematology | No | 2023-04-26 |
| System, Test, Low Density, Lipoprotein | MRR | Class 1 | Clinical Chemistry | No | 2023-04-26 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-14 |
| Magnifier, Hand-Held, Low-Vision | HJF | Class 1 | Ophthalmic | No | 2025-08-26 |
| Hydrazone Colorimetry, Ast/Sgot | CIS | Class 2 | Clinical Chemistry | No | 2026-02-09 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2024-05-21 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2024-05-21 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2024-05-21 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2024-05-21 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Detergent | JCB | Class 1 | Pathology | No | 2024-05-21 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2023-04-26 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2023-04-26 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2026-06-18 |
| Hydrazone Colorimetry, Alt/Sgpt | CKD | Class 1 | Clinical Chemistry | No | 2026-02-09 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-05-22 |
| Acid, Uric, Uricase (Oxygen Rate) | JHC | Class 1 | Clinical Chemistry | No | 2022-12-22 |
| Solution, Copper Sulfate For Specific Gravity Determinations | KSL | Class 1 | Hematology | No | 2017-06-14 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2024-05-21 |
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,
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
DxU 1800 System Bridge
PL 92/PL 92A/PL 92B Alanine Aminotransferase Test Strip
URIT U10 Uric Acid Test Strip
PA-11/PA-11A Uric Acid Meter and Strips
URIT U10 Uric Acid Test Strip, PA 11 Uric Acid Test Strip, PA 16 Uric Acid Test Strip
URIT-10 Uric Acid Meter
PA-16/16A Uric Acid Meter and Strips
URITEST 13G URINE REAGENT STRIPS
URITEST 11G URINE REAGENT STRIPS
HTI CL-50 Plus Urine Analyzer
UrineRS-13, Urine Strips
UrineRS-10, Urine Strips
UrineRS-11, Urine Strips
URITEST 10G URINE REAGENT STRIPS
HTI CL-500 Urine Analyzer
URITEST-50 AND URITEST-500B URINE ANALYZER
UrineRS-11-MA, Urine Strips
DxU Multiple Control for SG
DxU Turbidity Control
DxU SG Calibrator
URIT YC 2ST Calibrator Solution For Urine Analyzer
UQ-14 Urinalysis Control, URIT YQ 3STC Quality Control Solution For Urine Analyzer,
DxU 11 Urinalysis Control
DxU SG Control
DxU Color Control
UQC-4SG Quality Control Solution for Urine Analyzer
UQ-11 Urinalysis Control
DxU Turbidity Calibrator
DxU 14 Urinalysis Control
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)