Changchun Merydi BIO-Tech Co., Ltd.
Registered establishment in Changchun, Jilin, China. 24 device types.
Changchun Merydi BIO-Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Paper, Obstetric Ph, Kit, Screening, Urine and 22 other device types. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | CHANGCHUN MERYDI BIO-TECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3038206980 |
| FEI number | 3038206980 |
| Establishment type | Manufacturer |
Location
| City | Changchun |
|---|---|
| Province | Jilin |
| Address | Room 302, 304a, Block A, Incubation Building, No. 191, Chaoqun Street, High-tech Development Zone, Changchun C |
| Postal code | 130000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | Class 1 | Acid Ascorbic, Acid Test | 2025 | 10 |
| Acid, Uric, Uricase (Colorimetric) | Class 1 | Uric Acid test | 2025 | 6 |
| Antisera, All Types, Escherichia Coli | Class 1 | Escherichia coli test (colloidal gold), Escherichia coli test (powder), antisera, all types, escherichia coli | 2025 | 3 |
| Antisera, Fluorescent, All Globulins, Salmonella Spp. | Class 2 | Salmonella test (fluorescence analysis), Salmonella test (colloidal gold), Salmonella (fluorescence analysis) | 2025 | 3 |
| Automated Urinalysis System | Class 1 | Semi-Automatic Urine Analyzer, Automated Urinalysis system | 2025 | 16 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Class 1 | Urinary Test Non-Quant, AZO-DYES, colorimetric, bilirubin & its conjugates (urinary, non-quant.) | 2025 | 12 |
| Conversion To Creatinine, Creatine | Class 1 | Creatinine | 2025 | 3 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class 1 | nitrite Urinary Test Non-Quant, Nitric oxide test, URS-3N test strip, Diazo (Colorimetric), Nitrite (Urinary, NON-Quant) | 2025 | 14 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Class 1 | diazonium colorimetry, urobilinogen (urinary, non-quant.), Urinary Test Non-Quant., Diazonium colorimetry, Urobilinogen | 2025 | 11 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class 1 | pH Paper Test Strips Kit for Results in Seconds with Litmus Paper, pH Scale 4.5-9, dye-indicator, ph (urinary,non-quantitative), pH Testing Strips 120ct, Body pH Levels Test Strips to Track and Monitor Your pH Balance Test Strips for Women, Urinary Test Non-Quant., PH, URS-3N test strip and 3 more | 2025 | 16 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Water Test Strips, Reagent Strips For Water; Zearalenone Quantitative Test(Time-ResolvedfluoroimmunoasSay), Oil Test Strip, B1 Vomitoxin QuantitativeTest(Time-Res Olvedfuoroimmunoassay), Alatoxin B1 Quantitative Test(Time-Resolved Fluoroimmunoassay) | 2025 | 72 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Class 1 | Urine Test Strip for Albumin-to-Creatinine Ratio, Urinary Test Non-Quant., Protein, Micro Albumin | 2025 | 14 |
| Kit, Screening, Urine | Class 1 | VC, Lead Test Swab, Test For The Concentration of Ortho-phthalaldehyde test, aflatoxin (colloidal gold), Urine Magnesium test, Urine Zinc Test and 2 more | 2025 | 7 |
| Material, Quality Control, Semen Analysis | Class 2 | Male Sperm Count Test | 2025 | 3 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | Class 1 | Urinary Test Non-Quant., Nitroprusside, Ketone Test Strip; ketones (urinary, non-quant.) | 2025 | 17 |
| Paper, Obstetric Ph | Class 1 | Vaginal PH Test Strip | 2025 | 13 |
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | Class 1 | Total chlorine, Free chlorine, Bromine, Nitrate, Nitrite, hydrogen sulfide, manganese, sulfate, zinc, sodium chloride, Fluoride, Chromium/Cr, Copper, Lead, Hg, Iron, Cyanuric acid, pH, Hardness, Total alkalinity, Carbonate root; | 2025 | 14 |
| Qualitative Chemical Reactions, Urinary Calculi (Stone) | Class 1 | qualitative chemical reactions, urinary calculi (stone) | 2025 | 3 |
| Solution, Copper Sulfate For Specific Gravity Determinations | Class 1 | specific gravity | 2025 | 5 |
| Solution, Formol Calcium | Class 1 | Calcium | 2025 | 3 |
| Sperm, Antigen, Antiserum, Control | Class 1 | Male Sperm Count Test | 2025 | 5 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | One step FSH rapid test | 2025 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Ovulation Urine Test Strip | 2025 | 38 |
| Test, Urine Leukocyte | Class 1 | UTI Test strip, URS-3N test strip, urine leukocyte | 2025 | 16 |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Dirui Industrial Co., Ltd. | 84 |
| Changchun Wancheng BIO-Electron Co., Ltd. | 34 |
| Jilin Hongyi BIO-Tech Co., Ltd. | 24 |
| Changchun LYZ Technology Co., Ltd. | 16 |
| Jilin Test BIO-Electron Co., Ltd. | 9 |
| Sincera Technology (Changchun) Co., Ltd. | 2 |
| Sino-Dentex Co., Ltd. | 2 |
| Changchun AIK Medical Devices Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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