BEUDAMED
    FDA Registration Active 🇨🇳 China

    SAFECARE BIOTECH(HANGZHOU)CO.,LTD

    Reg #: 3013077867 · FEI: 3013077867 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    99
    Establishment Types
    1
    Classifications
    22

    Registration Details

    Registration Name
    SAFECARE BIOTECH(HANGZHOU)CO.,LTD
    Registration Number
    3013077867
    FEI Number
    3013077867
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.689, Changxing Avenue, Taihu Street,, Changxing County
    City
    Huzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242767

    Owner / Operator

    Firm Name
    Safecare Biotech(Hangzhou)Co.,Ltd
    Operator Number
    10052102
    Address
    Building 2/203 No.18 Haishu Rd.,, Cangqian Sub-district,Yuhang District
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    311121
    Country
    CN
    Correspondent
    Alex Qiu

    Products

    Device Name Product Code
    Test, Urine Leukocyte LJX
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Test, Opiates, Over The Counter NGL
    Paper, Obstetric Ph LNW
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Amphetamine, Over The Counter NFT
    Test, Morphine, Over The Counter NGI
    Test, Cannabinoid, Over The Counter NFW
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Methamphetamine, Over The Counter NGG
    Test, Propoxyphene, Over The Counter QBF
    Test, Benzodiazepine, Over The Counter NFV
    Test, Methadone, Over The Counter PTG
    Test, Barbiturate, Over The Counter PTH
    Test System, Nicotine, Cotinine, Metabolites MRS
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Amphetamine DKZ

    Proprietary Names

    Safecare Urinary Tract Infection Test Cubtale Ovulation (LH) Test Strip SAFECARE Luteinizing Hormone Rapid Test Midstream SAFECARE Luteinizing Hormone Rapid Test Strip SAFECARE Luteinizing Hormone Rapid Test Device TTestahead Luteinizing Hormone Rapid Test Device Welcheck Luteinizing Hormone Rapid Test Strip Welcheck Luteinizing Hormone Rapid Test Midstream FIRSTVIEW Luteinizing Hormone Rapid Test Midstream FIRSTVIEW Luteinizing Hormone Rapid Test Strip Unicare Luteinizing Hormone Rapid Test Strip Unicare Luteinizing Hormone Rapid Test Midstream FIRSTVIEW Luteinizing Hormone Rapid Test Device Wholesome Story Ovulation(LH) Test Strip TTestahead Luteinizing Hormone Rapid Test Strip TTestahead Luteinizing Hormone Rapid Test Midstream Welcheck Luteinizing Hormone Rapid Test Device Unicare Luteinizing Hormone Rapid Test Device hCG Urine Test Midstream hCG Urine Test Cassette hCG Urine Test Strip Safecare FYL Urine Test Cassette Safecare Fentanyl Urine Test Cassette FIRSTVIEW FYL Urine Test Cassette FIRSTVIEW Fentanyl Urine Test Cassette Firstview urinary tract infection Test Ttestahead urinary tract infection Test WelCheck Urinary Tract Infection Test Safecare urinary tract infection Test Firstview Vaginal PH Rapid Test Cassette TTestahead Vaginal PH Rapid Test Cassette WelCheck Vaginal pH Rapid Test Cassette Exploro Vaginal Health pH Test Device 2San Vaginal pH Rapid Test Cassette Safecare Vaginal PH Rapid Test Cassette Unicare Vaginal PH Rapid Test Cassette Cwhole Vaginal PH Rapid Test Cassette SAFECARE Multi-Drug Urine Test Cup SAFECARE Multi-Drug Urine Test Dip Card Safecare EDDP Urine Test Dipcard Safecare BUP Urine Test Dipcard Safecare OXY Urine Test Dipcard Safecare MDMA Urine Test Dipcard SAFECARE® Multi-Drug Urine Test Cup SAFECARE® Multi-Drug Urine Test Dip Card Safecare Multi-Drug Urine Test Dip Card Safecare Multi-Drug Urine Test Cup SAFECARE Multi-Drug Urine Test DipCard SAFECARE COT Saliva Cup Test SAFECARE COT Urine Cassette Test SAFECARE COT Urine Dip card Test SAFECARE COT Saliva Dip Card Test SAFECARE COT Saliva Cassette Test SAFECARE COT Urine Strip Test FIRSTVIEW COT Urine Strip Test EXPLORO Highly Sensitive NICOTINE URINE TEST FIRSTVIEW COT Saliva Cup Test FIRSTVIEW COT Saliva Dip Card Test TTestahead Cotinine(COT) Urine Test Dipcard FIRSTVIEW COT Urine Cassette Test FIRSTVIEW COT Saliva Cassette Test TTestahead COT Urine Strip Test FIRSTVIEW COT Urine Dip card Test TTestahead COT Saliva Cup Test UNICARE COT Saliva Dip Card Test Welcheck COT Saliva Cassette Test Welcheck COT Saliva Cup Test Welcheck COT Urine Strip Test Welcheck COT Saliva Dip Card Test TTestahead COT Urine Cassette Test UNICARE COT Urine Strip Test TTestahead COT Saliva Dip Card Test Welcheck COT Urine Dip card Test TTestahead COT Urine Dip card Test UNICARE COT Saliva Cup Test UNICARE COT Urine Cassette Test Welcheck COT Urine Cassette Test UNICARE COT Urine Dip card Test TTestahead COT Saliva Cassette Test UNICARE COT Saliva Cassette Test SAFECARE® THC Urine Strip Test Unicare FSH Rapid Test Cassette(Urine) Firstview FSH Rapid Test Strip(Urine) Firstview FSH Rapid Test Midstream(Urine) TTestahead FSH Rapid Test Midstream(Urine) Safecare FSH Rapid Test Midstream(Urine) Safecare FSH Rapid Test Strip(Urine) Firstview FSH Rapid Test Cassette(Urine) TTestahead FSH Rapid Test Cassette(Urine) Welcheck FSH Rapid Test Midstream(Urine) Welcheck FSH Rapid Test Cassette(Urine) Unicare FSH Rapid Test Midstream(Urine) Welcheck FSH Rapid Test Strip(Urine) TTestahead FSH Rapid Test Strip(Urine) Safecare FSH Rapid Test Cassette(Urine) Unicare FSH Rapid Test Strip(Urine) SAFECARE Urine Test Cocaine SAFECARE Urine Test Amphetamine SAFECARE Urine Test Marijuana

    Establishment Types

    Manufacture Medical Device