FDA Registration
Active
🇨🇳 China
Urine Analyzer
Reg #: 3016860442
·
FEI: 3016860442
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- MEDSINGLONG CO LTD
- Registration Number
- 3016860442
- FEI Number
- 3016860442
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 1st,4th,5th, No 85th, 89th,Baiyun Road, Shiqiao Street, Panyu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K091472
Owner / Operator
- Firm Name
- MEDSINGLONG CO LTD
- Operator Number
- 10085385
- Address
- Floor 1st,4th,5th, No 85th, 89th,Baiyun Road, Shiqiao Street, Panyu District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 511400
- Country
- CN
US Agent
- Business Name
- MEDRIGHT TECH INC
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2022-08-10 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2022-08-10 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2022-08-10 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2022-08-10 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2022-08-10 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2022-08-10 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2022-08-10 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2022-08-10 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2022-08-10 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2022-08-10 |
Proprietary Names
Urine Analyzer
Establishment Types
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device