FDA Registration
Active
🇨🇳 China
UrineRS-11, Urine Strips
Reg #: 3010891909
·
FEI: 3010891909
·
Expires 2025
Products
12
Proprietary Names
10
Establishment Types
2
Classifications
12
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
- K082811
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 |
|---|---|---|---|---|---|
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2017-06-14 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2017-06-14 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2017-06-14 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2017-06-14 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2017-06-14 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2017-06-14 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2017-06-14 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2017-06-14 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2017-06-14 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2017-06-14 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2017-06-14 |
| Solution, Copper Sulfate For Specific Gravity Determinations | KSL | Class 1 | Hematology | No | 2017-06-14 |
Proprietary Names
UrineRS-11, Urine Strips
URITEST 11G URINE REAGENT STRIPS
URITEST-50 AND URITEST-500B URINE ANALYZER
URITEST 10G URINE REAGENT STRIPS
HTI CL-50 Plus Urine Analyzer
HTI CL-500 Urine Analyzer
URITEST 13G URINE REAGENT STRIPS
UrineRS-13, Urine Strips
UrineRS-11-MA, Urine Strips
UrineRS-10, Urine Strips
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)