Changchun Wancheng BIO-Electron Co., Ltd.
Registered establishment in Changchun, Jilin, China. 34 device types.
Changchun Wancheng BIO-Electron Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Paper, Obstetric Ph, Kit, Screening, Urine and 32 other device types. Its earliest product listing with the FDA dates from 2015.
34device types registered with the FDA
11recalls
Registration
| Registered name | CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008987086 |
| FEI number | 3008987086 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 长春万成生物电子工程有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Changchun |
|---|---|
| Province | Jilin |
| Address | No. 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, Jilin |
| 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 Test, Acid Ascorbic, Ascorbate | 2015 | 10 |
| Acid, Uric, Uricase (Colorimetric) | Class 1 | Uric Acid test | 2021 | 6 |
| Antisera, All Types, Escherichia Coli | Class 1 | antisera, all types, escherichia coli, Escherichia coli test (colloidal gold), Escherichia coli test (powder) | 2021 | 3 |
| Antisera, Fluorescent, All Globulins, Salmonella Spp. | Class 2 | Salmonella test (colloidal gold), Salmonella test (fluorescence analysis), Salmonella (fluorescence analysis), get Tested Salmonella Test | 2021 | 3 |
| Automated Urinalysis System | Class 1 | Automated Urinalysis system, Semi-Automatic Urine Analyzer | 2015 | 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.) | 2015 | 12 |
| Conversion To Creatinine, Creatine | Class 1 | Creatinine | 2017 | 3 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class 1 | URIMED Strips, Nitric oxide test, Diazo (Colorimetric), Nitrite (Urinary, NON-Quant), URS 3N teststrip, nitrite Urinary Test Non-Quant | 2015 | 14 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Class 1 | diazonium colorimetry, urobilinogen (urinary, non-quant.), Urinary Test Non-Quant., Diazonium colorimetry; Urobilinogen | 2015 | 11 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | Class 1 | Body pH Levels Test Strips to Track and Monitor Your pH Balance Test Strips for Women, JNW PH Test Strips – 4.5-9 PH 200 Pack, pH Testing Strips 120ct; Universal Ph Test Strip (4.5 – 9), JNW pH Test Strips 4.5-9, Gastric Aspirate ph test, JNW pH Test Strips 0-14 and 5 more | 2015 | 16 |
| Enzyme Immunoassay, Amphetamine | Class 2 | Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;, Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card | 2024 | 16 |
| Enzyme Immunoassay, Barbiturate | Class 2 | Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;, Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card | 2024 | 12 |
| Enzyme Immunoassay, Benzodiazepine | Class 2 | Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;, Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card | 2024 | 13 |
| Enzyme Immunoassay, Cannabinoids | Class 2 | Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;, Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card | 2024 | 18 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class 2 | Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;, Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card | 2024 | 16 |
| Enzyme Immunoassay, Methadone | Class 2 | Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;, Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card | 2024 | 11 |
| Enzyme Immunoassay, Opiates | Class 2 | Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;, Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card | 2024 | 17 |
| Enzyme Immunoassay, Phencyclidine | Class U | Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;, Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card | 2024 | 16 |
| Enzyme Immunoassay, Propoxyphene | Class 2 | Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;, Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card | 2024 | 10 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Alatoxin B1 Quantitative Test(Time-Resolved Fluoroimmunoassay), Zearalenone Quantitative Test(Time-ResolvedfluoroimmunoasSay), JNW Drinking Water Test Strips – 17-in-1 100 Pack, Oil Test Strip, B1 Vomitoxin QuantitativeTest(Time-Res Olvedfuoroimmunoassay), JNW Water Hardness Test Strips -150ct and 2 more | 2018 | 72 |
| Gas Chromatography, Methamphetamine | Class 2 | Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card;, Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card | 2024 | 10 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Class 1 | Urinary Test Non-Quant., Protein, Micro Albumin, Urine Test Strip for Albumin-to-Creatinine Ratio | 2015 | 14 |
| Kit, Screening, Urine | Class 1 | Free Radical test, Urine Salinity test, Urine Magnesium test, Lead Test Swab, aflatoxin (colloidal gold), Lead test (colloidal gold) and 3 more | 2021 | 7 |
| Material, Quality Control, Semen Analysis | Class 2 | Atifer Fertility Sperm Count Test for Men, get Tested sperm test, Palinoia ProGenix male fertility test, Male Sperm Count Test | 2023 | 3 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | Class 1 | Urinary Test Non-Quant., Nitroprusside, Ketone Test Strip, ketones (urinary, non-quant.) | 2015 | 17 |
| Paper, Obstetric Ph | Class 1 | Vaginal PH Test Strip | 2021 | 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, JNW Chlorine Test Strips – 100 Pack | 2022 | 14 |
| Qualitative Chemical Reactions, Urinary Calculi (Stone) | Class 1 | qualitative chemical reactions, urinary calculi (stone) | 2023 | 3 |
| Solution, Copper Sulfate For Specific Gravity Determinations | Class 1 | specific gravity | 2018 | 5 |
| Solution, Formol Calcium | Class 1 | Calcium | 2017 | 3 |
| Sperm, Antigen, Antiserum, Control | Class 1 | Fericare Male Fertility Test, Exploro Highly Male Fertility/Sperm Concentration Test, Atifer Fertility Sperm Count Test for Men, Male Sperm Count Test, get Tested sperm test, Palinoia ProGenix male fertility test and 1 more | 2021 | 5 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | One step FSH rapid test | 2024 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | Ovulation Urine Test Strip | 2021 | 38 |
| Test, Urine Leukocyte | Class 1 | test, urine leukocyte, Urine Test; URS 3N teststrip | 2015 | 16 |
Clearances
No clearance names Changchun Wancheng BIO-Electron Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232228 | 2024-02-23 | DJG | Traditional | Shanghai Accurature Diagnostics Co., Ltd. |
Recalls
11 of these are Class II. Class II means a temporary or reversible health consequence. 11 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 4,800 |
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 500 |
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 1,000 |
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 1,000 |
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 500 |
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 1,000 |
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 3,300 |
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 32,500 |
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 91,366 |
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 3,000 |
| 2025-11-22 | Class II | No Marketing Application | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead t | 1,000 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Factory area | 27,000 sqm |
| Main products | Urine test strips, Water test strips, Rapid detection test kits, Urine analyzer, Blood cell analyzer |
| Certifications | FDA, CE, cGMP, ISO 13485, ISO 9001 |
| Export markets | 100+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Dirui Industrial Co., Ltd. | 84 |
| Changchun Merydi BIO-Tech Co., Ltd. | 24 |
| 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.
The manufacturer named here can complete this record.