BEUDAMED
    FDA Registration Active 🇨🇳 China

    JIANERKANG MEDICAL CO., LTD.

    Reg #: 9616874 · FEI: 3006403682 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    26
    Establishment Types
    4
    Classifications
    17

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    Registration Details

    Registration Name
    JIANERKANG MEDICAL CO., LTD.
    Registration Number
    9616874
    FEI Number
    3006403682
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.1 Jianerkang Road, Industrial Zone, Zhixi Town, Jintan District
    City
    Changzhou City Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K112110

    Owner / Operator

    Firm Name
    JIANERKANG MEDICAL CO., LTD.
    Operator Number
    9041776
    Address
    No.1 Jianerkang Road, Industrial Zone, Zhixi Town, Jintan District
    City
    Changzhou City
    State
    Jiangsu
    Postal Code
    213251
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Gauze / Sponge,Nonresorbable For External Use NAB
    Container, Specimen, Non-Sterile NNI
    Dressing, Wound, Occlusive NAD
    Gauze/Sponge, Internal EFQ
    Dressing, Wound, Drug FRO
    Fiber, Medical, Absorbent FRL
    Lubricant, Patient KMJ
    Tubing, Noninvasive GAZ
    Bandage, Liquid, Skin Protectant NEC
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Tray, Surgical, Instrument FSM
    Tape And Bandage, Adhesive KGX
    Bandage, Cast ITG
    Media, Coupling, Ultrasound MUI
    Bandage, Elastic FQM
    Solvent, Adhesive Tape KOX

    Proprietary Names

    Gauze sponge, gauze swab, non woven sponge, conforming bandage, fluffy gauze bandage roll, fluffy gauze spong Dressing Pack for Heavy Drainage; Dressing Pad Combined Absorbent; Dry Wipes; gauze sponge; Gauze Swabs 100% Cotton Absorbent Gauze Roll 100% cotton; Burn Pad; Cotton Ball; Dental Roll 100% cotton; Dressing Pack for Heavy Drainage; Dressing Pack for Heavy Drainage; Dressing Pad Combined Absorbent; Dry Wipes; gauze sponge; Gauze Swabs 100% Cotton; CONTAINER, SPECIMEN, NON-STERILE Operating Room Towels Absorbent Patient Underpad GAUZE SPONGE, NON WOVEN SPONGE OR TOWEL, SURGICAL TOWEL OR TOWEL STERILE OR NON STERILE LUBRICANT PATIENT STERILE LUBRICATING JELLY Connecting tube suction tubing, connecting tube Bandage, liquid, skin protectant Sterile Lubricating Jelly Humidifier, Respiratory Gas, (Direct Patient Interface) AquaPak Humidifier Adapters; Aquapak Sterile Humidifier Reservoirs; AquaPak Bubble Prefilled Humidif Aquapak Prefilled Humidifier LAP SPONGE LAP SPONGE WITH X-RAY Lap Sponge - X-ray detectable HERMATIGE HOSPITAL PRO Sterile and Non-Sterile Ultrasound Gels; Media, Coupling, Ultrasound ELASTIC BANDAGE, STRETCH BANDAGE REMOVER ADHESIVE TAPE

    Establishment Types

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