BEUDAMED
    FDA Registration Active 🇨🇳 China

    Yantai Addcare Bio-Tech Co., Ltd.

    Reg #: 3010031137 · FEI: 3010031137 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    30
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    Yantai Addcare Bio-Tech Co., Ltd.
    Registration Number
    3010031137
    FEI Number
    3010031137
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.10, Nanjing Street, Development Zone
    City
    Yantai Shandong
    Country
    CN

    Owner / Operator

    Firm Name
    Yantai Addcare Bio-Tech Co., Ltd.
    Operator Number
    10054662
    Address
    No.10, Nanjing Street, Development Zone
    City
    Yantai
    State
    Shandong
    Postal Code
    265501
    Country
    CN

    Products

    Device Name Product Code
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Bath, Incubators/Water, All JTQ
    Fluorometer, For Clinical Use KHO
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Clinical Sample Concentrator JJH
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use JJC
    Station, Pipetting And Diluting, For Clinical Use JQW

    Proprietary Names

    Vacuum Tube Labeling System Rodeman Microplate washer iWash8/12 Automated Medical Laboratory Workflow Platform LineTo-3000C, LineTo-2000D Automated Medical Laboratory Workflow Platform Flow Fluore 200, LineTo-5000 Semi-automatic Gelcard incubator R-24C Fully Automated FIA Analyzer(ADC FIA 800,ADC FIA 600,ADC FIA 400,ADC FIA 200) Centrifuge(NJ-24, NJ-12, AC-80) Fully Automated Nucleic Acid Extractor; NA4048,NA4424,NA4316,NA2316,NA2324,NA2224,NA1116,NA1216; Nexor 32M, Nexor 32 Nexor 96, ADC CH616, ADC CH196 Fully Automated Nucleic Acid Extractor NA2288 ELISA Reader DM 880L ADC CLIA 800,ADC CLIA 600,ADC CLIA 500,ADC CLIA 400,ADC CLIA 300,ADC CLIA 200 Chemiluminescence Reader JUDE 96 Fully Automated CLIA workstation iTube 3000, iTube 5000 ELISA Reader DM 801, DM 801B Fully Automated Biochemistry Analyzer BC-400, BC-600, BC-2000 Fully Automated CLIA Workstation iTube 1000 Fully Automated CLIA and ELISA Workstation ICE 800, ICE 400 Fully automated blood grouping system Blozer 200, Blozer 150, Blozer 120, Blozer 100, Blozer 72 Fully Automated ELISA Analyzer ELISA 880, ELISA 480, ELISA 280 Fully Automated ELISA Workstation Fully Automated Liquid Handling System ASP 150,ASP100,ASP75 ADC ELISA 200,ADC ELISA 180 ADC ELISA 2200,ADC ELISA 1800,ADC ELISA 1100,ADC ELISA 800,ADC ELISA 600,ADC ELISA 500,ADC ELISA 400,ADC ELISA 300 Automated Liquid Handling System SPS 1000 Fully Automated ELISA Analyzer ELISA 1600/1200/800/400/200/100 Automated Liquid Handling System SPS 4000 Fully Automated ELISA Workstation ADC ELISA 400A Fully Automated ELISA Workstation ADC ELISA 190 Fully Automated ELISA Workstation ADC ELISA 800Pro

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device