BEUDAMED
    FDA Registration Active 🇨🇳 China

    CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.

    Reg #: 3008987086 · FEI: 3008987086 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    76
    Establishment Types
    3
    Classifications
    34

    Registration Details

    Registration Name
    CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.
    Registration Number
    3008987086
    FEI Number
    3008987086
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, Jilin
    City
    Changchun Jilin
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232228

    Owner / Operator

    Firm Name
    Changchun Wancheng Bio-Electron Co., Ltd.
    Operator Number
    10049606
    Address
    No. 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, Jilin
    City
    Changchun
    State
    Jilin
    Postal Code
    130000
    Country
    CN
    Correspondent
    Yanru Zhang

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Antisera, Fluorescent, All Globulins, Salmonella Spp. GOO
    Solution, Formol Calcium IGD
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Sperm, Antigen, Antiserum, Control DFQ
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Acid, Uric, Uricase (Colorimetric) KNK
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Antisera, All Types, Escherichia Coli GNA
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Enzyme Immunoassay, Barbiturate DIS
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Propoxyphene JXN
    Enzyme Immunoassay, Benzodiazepine JXM
    Enzyme Immunoassay, Opiates DJG
    Gas Chromatography, Methamphetamine LAF
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Phencyclidine LCM
    Enzyme Immunoassay, Methadone DJR
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Qualitative Chemical Reactions, Urinary Calculi (Stone) JNQ
    Paper, Obstetric Ph LNW
    Automated Urinalysis System KQO
    Solution, Copper Sulfate For Specific Gravity Determinations KSL
    Kit, Screening, Urine JXA
    Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) JRS
    Conversion To Creatinine, Creatine JLA
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Material, Quality Control, Semen Analysis NRF
    Test, Urine Leukocyte LJX

    Proprietary Names

    Salmonella test (fluorescence analysis) Salmonella (fluorescence analysis) Salmonella test (colloidal gold) get Tested Salmonella Test Calcium Ovulation Urine Test Strip Male Sperm Count Test TREA Male Fertility Test get Tested sperm test Fericare Male Fertility Test Exploro Highly Male Fertility/Sperm Concentration Test Palinoia ProGenix male fertility test Atifer Fertility Sperm Count Test for Men Acid Ascorbic Acid Test Ascorbate diazonium colorimetry, urobilinogen (urinary, non-quant.) Urinary Test Non-Quant., Diazonium colorimetry; Urobilinogen Uric Acid test Urinary Test Non-Quant., Nitroprusside Ketone Test Strip ketones (urinary, non-quant.) Escherichia coli test (powder) Escherichia coli test (colloidal gold) antisera, all types, escherichia coli Urine Test Strip for Albumin-to-Creatinine Ratio Urinary Test Non-Quant., Protein Micro Albumin Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card; URS 3N teststrip URIMED Strips nitrite Urinary Test Non-Quant Nitric oxide test DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) qualitative chemical reactions, urinary calculi (stone) Vaginal PH Test Strip Automated Urinalysis system Semi-Automatic Urine Analyzer specific gravity Free Radical test aflatoxin (colloidal gold) Urine Salinity test Test For The Concentration of Ortho-phthalaldehyde test JNW Direct Lead Test Swabs - 10 pack Lead Test Swab Lead test (colloidal gold) Urine Magnesium test Urine Zinc Test; VC Total chlorine, Free chlorine, Bromine, Nitrate, Nitrite, hydrogen sulfide, manganese, sulfate, zinc, sodium chloride JNW Chlorine Test Strips - 100 Pack Fluoride, Chromium/Cr, Copper, Lead, Hg, Iron, Cyanuric acid, pH, Hardness, Total alkalinity, Carbonate root Creatinine Urinary Test Non-Quant, AZO-DYES colorimetric, bilirubin & its conjugates (urinary, non-quant.) One step FSH rapid test JNW pH Test Strips 4.5-9 pH Testing Strips 120ct; Universal Ph Test Strip (4.5 - 9) Urinary Test Non-Quant., PH pH 0-14; pH Paper Test Strips Kit for Results in Seconds with Litmus Paper, pH Scale 4.5-9 JNW PH Test Strips - 4.5-9 PH 200 Pack dye-indicator, ph (urinary,non-quantitative) Gastric Aspirate ph test JNW pH Test Strips 0-14 Body pH Levels Test Strips to Track and Monitor Your pH Balance Test Strips for Women JNW PH Test Strips - 0-14 PH 200 Pack Water Test Strips, Reagent Strips For Water Zearalenone Quantitative Test(Time-ResolvedfluoroimmunoasSay) Oil Test Strip Alatoxin B1 Quantitative Test(Time-Resolved Fluoroimmunoassay) JNW Drinking Water Test Strips - 17-in-1 100 Pack JNW Water Hardness Test Strips -150ct JNW Water Hardness Test Strips - 100 Pack B1 Vomitoxin QuantitativeTest(Time-Res Olvedfuoroimmunoassay) test, urine leukocyte Urine Test; URS 3N teststrip

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device