Skip to the page
Get started free

Data / Medical devices / China / Changchun Wancheng Bio-Electron Co., Ltd.

Changchun Wancheng Bio-Electron Co., Ltd.: FDA-registered device maker in Changchun Jilin, China, 1 510(k) clearance

Changchun Wancheng Bio-Electron Co., Ltd. is registered with the FDA (registration 3008987086) in Changchun Jilin, China. It lists 34 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Changchun Wancheng Bio-Electron Co., Ltd.
FDA registration number
3008987086
Address
No. 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, Jilin, Changchun Jilin, China, 130000
Owner or operator
Changchun Wancheng Bio-Electron Co., Ltd. (10049606)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
June 27, 2015
Registered through
2026
Brand names listed
Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card, Acid Ascorbic, Acid Test, Alatoxin B1 Quantitative Test(Time-Resolved Fluoroimmunoassay), Ascorbate, Atifer Fertility Sperm Count Test for Men, Automated Urinalysis system, B1 Vomitoxin QuantitativeTest(Time-Res Olvedfuoroimmunoassay) and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)JMA1Manufactureraccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Manufactureraccessdata.fda.gov
Antisera, All Types, Escherichia ColiGNA1Manufactureraccessdata.fda.gov
Antisera, Fluorescent, All Globulins, Salmonella Spp.GOO2Manufactureraccessdata.fda.gov
Automated Urinalysis SystemKQO1Manufactureraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Manufactureraccessdata.fda.gov
Conversion To Creatinine, CreatineJLA1Contract manufacturer, Manufactureraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Manufactureraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Manufactureraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMURepackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Repackager or relabeleraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Manufactureraccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Repackager or relabeleraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Manufactureraccessdata.fda.gov
Kit, Screening, UrineJXA1Manufactureraccessdata.fda.gov
Material, Quality Control, Semen AnalysisNRF2Manufactureraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Manufactureraccessdata.fda.gov
Paper, Obstetric PhLNW1Manufactureraccessdata.fda.gov
Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)JRS1Manufactureraccessdata.fda.gov
Qualitative Chemical Reactions, Urinary Calculi (Stone)JNQ1Manufactureraccessdata.fda.gov
Solution, Copper Sulfate For Specific Gravity DeterminationsKSL1Contract manufacturer, Manufactureraccessdata.fda.gov
Solution, Formol CalciumIGD1Contract manufacturer, Manufactureraccessdata.fda.gov
Sperm, Antigen, Antiserum, ControlDFQ1Manufactureraccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Manufactureraccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Manufactureraccessdata.fda.gov
Test, Urine LeukocyteLJX1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 23, 2024K232228Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip CardDJGSubstantially EquivalentShanghai Accurature Diagnostics Co., Ltd.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
November 22, 202597801Class IIOngoingLotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ETest 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 to inappropriate medical intervention.accessdata.fda.gov

Compare with other makers

Updated February 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.