FDA Registration
Active
🇨🇳 China
JILIN HONGYI BIO-TECH CO., LTD.
Reg #: 3043127699
·
FEI: 3043127699
·
Expires 2026
Products
24
Proprietary Names
31
Establishment Types
2
Classifications
24
Registration Details
- Registration Name
- JILIN HONGYI BIO-TECH CO., LTD.
- Registration Number
- 3043127699
- FEI Number
- 3043127699
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 729, 730, 731, Building G1, Phase II, Changchun Beihu Science and Technology Park, Beihu Science and Technology Development Zone
- City
- Changchun Jilin
- Country
- CN
Owner / Operator
- Firm Name
- Jilin Hongyi Bio-Tech Co., Ltd.
- Operator Number
- 10094749
- Address
- Room 729, 730, 731, Building G1, Phase II, Changchun Beihu Science and Technology Park, Beihu Science and Technology Development Zone
- City
- Changchun
- State
- Jilin
- Postal Code
- 130102
- Country
- CN
- Correspondent
- Hongting Wang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | JRS | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Conversion To Creatinine, Creatine | JLA | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Kit, Screening, Urine | JXA | Class 1 | Microbiology | No | 2025-12-20 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2025-12-20 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Solution, Copper Sulfate For Specific Gravity Determinations | KSL | Class 1 | Hematology | No | 2025-12-20 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Antisera, Fluorescent, All Globulins, Salmonella Spp. | GOO | Class 2 | Microbiology | No | 2025-12-20 |
| Sperm, Antigen, Antiserum, Control | DFQ | Class 1 | Immunology | No | 2025-12-20 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Qualitative Chemical Reactions, Urinary Calculi (Stone) | JNQ | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Antisera, All Types, Escherichia Coli | GNA | Class 1 | Microbiology | No | 2025-12-20 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Material, Quality Control, Semen Analysis | NRF | Class 2 | Hematology | No | 2025-12-20 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Solution, Formol Calcium | IGD | Class 1 | Pathology | No | 2025-12-20 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2025-12-20 |
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2025-12-20 |
Proprietary Names
Acid Ascorbic; Acid Test
Fluoride, Chromium/Cr, Copper, Lead, Hg, Iron, Cyanuric acid, pH, Hardness, Total alkalinity, Carbonate root;
Total chlorine, Free chlorine, Bromine, Nitrate, Nitrite, hydrogen sulfide, manganese, sulfate, zinc,
sodium chloride
Creatinine
Aflatoxin (Colloidal Gold); Free Radical Test; Lead Test (Colloidal Gold); Lead Test Swab;
Test For The Concentration of Ortho-phthalaldehyde Test; Urine Magnesium Test; Urine Salinity Test; Urine Zinc Test; VC
Uric Acid Test
Urine leukocyte; UTI Test strip; URS-3N test strip
Reagent Strips For Water; Zearalenone Quantitative Test (Time-ResolvedfluoroimmunoasSay)
B1 Vomitoxin QuantitativeTest (Time-Res Olvedfuoroimmunoassay); Oil Test Strip; Water Test Strips,
Alatoxin B1 Quantitative Test (Time-Resolved Fluoroimmunoassay);
ph (urinary,non-quantitative); Gastric Aspirate ph test; pH 0-14;
Body pH Levels Test Strips to Track and Monitor Your pH Balance Test Strips for Women; dye-indicator,
Universal Ph Test Strip (4.5 - 9); Urinary Test Non-Quant., PH; URS-3N test strip, Yummy pH Alkaline Filter
pH Paper Test Strips Kit for Results in Seconds with Litmus Paper, pH Scale 4.5-9; pH Testing Strips 120ct;
Specific Gravity
One step FSH rapid test
Salmonella (fluorescence analysis); Salmonella test (colloidal gold); Salmonella test (fluorescence analysis)
Male Sperm Count Test
Ketone Test Strip; Ketones (urinary, non-quant); Urinary Test Non-Quant., Nitroprusside
Qualitative Chemical Reactions, Urinary Calculi (Stone)
Ovulation Urine Test Strip
Automated Urinalysis system; Semi-Automatic Urine Analyzer
DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT); Nitric oxide test; nitrite Urinary Test Non-Quant; URS-3N test strip
Antisera, All Types, Escherichia Coli; Escherichia Coli Test (Colloidal Gold); Escherichia Coli Test (Powder)
Colorimetric, Bilirubin & its conjugates (urinary, non-quant.); Urinary Test Non-Quant, AZO-DYES
Diazonium Colorimetry, Urobilinogen (Urinary, Non-quant.); Urinary Test Non-Quant., Diazonium Colorimetry; Urobilinogen
Calcium
Urinary Test Non-Quant., Protein; Urine Test Strip for Albumin-to-Creatinine Ratio; Micro Albumin
Vaginal PH Test Strip
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device