FDA Registration
Active
🇨🇳 China
UC-1800 Automatic Urine Analyzer; URIT 11FA, URIT 12FA Urine Reagent Strips
Reg #: 3010891909
·
FEI: 3010891909
·
Expires 2025
Products
13
Proprietary Names
1
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- URIT Medical Electronic Co., Ltd.
- Registration Number
- 3010891909
- FEI Number
- 3010891909
- Status
- Active
- Expiry Year
- 2025
- 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
US Agent
- Business Name
- URIT MEDICAL ELECTRONIC CO., LTD
- Contact Name
- Gary Titov
- Address
- 206 Williams St
- City
- Wrentham
- State
- MA
- ZIP
- 02093
- Country
- US
- [email protected]
- Phone
- 617 3889598
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| 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 |
| 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 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2024-05-21 |
| Automated Urinalysis System | KQO | 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 |
Proprietary Names
UC-1800 Automatic Urine Analyzer; URIT 11FA, URIT 12FA Urine Reagent Strips
Establishment Types
Manufacture Medical Device