BEUDAMED
    FDA Registration Active 🇨🇳 China

    TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD

    Reg #: 3005460813 · FEI: 3005460813 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    49
    Establishment Types
    4
    Classifications
    33

    Registration Details

    Registration Name
    TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD
    Registration Number
    3005460813
    FEI Number
    3005460813
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 18, Wuzhou (South) Road
    City
    Taizhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K182043

    Owner / Operator

    Firm Name
    Taizhou Xinkang Medical Materials Co., Ltd
    Operator Number
    10045001
    Address
    No. 18, Wuzhou (South) Road
    City
    Taizhou
    State
    Jiangsu
    Postal Code
    225300
    Country
    CN
    Correspondent
    Yujun Tang

    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
    First Aid Kit Without Drug OHO
    Mask, Oxygen, Non-Rebreathing KGB
    Vinyl Patient Examination Glove LYZ
    Non-Surgical Gown OEA
    Polymer Patient Examination Glove LZA
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Tracheotomy Care Kit NXA
    Forceps HTD
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Gauze / Sponge,Nonresorbable For External Use NAB
    Sling, Arm ILI
    Pad, Eye HMP
    Mask, Scavenging KHA
    Skin Prep Tray OJU
    Tape And Bandage, Adhesive KGX
    Light, Examination, Medical, Battery Powered KYT
    Mouthpiece, Breathing BYP
    Disinfectant, Medical Devices LRJ
    Emergency Obstetrical Kit OKU
    Bandage, Elastic FQM
    Bedding, Disposable, Medical KME
    Depressor, Tongue, Non-Surgical FMA
    Scissors, General, Surgical LRW
    Device, Pressure Applying KNM
    Solution, Isotonic JCE
    Pack, Hot Or Cold, Disposable IMD
    Clip, Removable (Skin) FZQ
    Dressing, Wound, Occlusive NAD
    Cotton, Roll EFN
    Fiber, Medical, Absorbent FRL
    Dressing, Compression MHW
    Dressing, Wound, Drug FRO
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC

    Proprietary Names

    First Aid Kit First Aid Case First Aid Bag CPR-Aid Rescuer Device, Single Use VINYL PATIENT EXAMINATION GLOVES Isolation Gown, CPE Thumb Loop Isolation Gowns Disposable Nitrile Gloves, Nitrile Examination Gloves, Nitrile Gloves Zeolite Hemostatic Gauze Tracheotomy care kit Plastic Tweezers, Plastic Forceps Powder Free Nitrile Patient Examination Glove Nitrile Glove Polymer Patient Examination Glove Non-Powdered Patient Examination Glove Medical Nitrile Glove ABSORBENT TIP APPLICATOR: COTTON TIP APPLICATOR Sterile Abdominal Wound Dressing Pads Gauze Sponges, Non-woven Gauze Sponges, Conbine Pad, Multi-trauma Dressing, Abdominal Pad, Non-adherent Pad Triangular Bandage Eye Pad Face Mask, Mouth To Mouth Mask Skin Prep Tray Surgical Tape (Clear/Cloth/Non-Woven/Waterproof) 1/2"x2 1/2y, 1/2"x3y, 1/2"x5y, 1/2"x10y, 1"x 5y, 1"x10y Adhesive Bandage 2"x3", 3"x4", 4"x4", 4"x6", 4"x8" Bandage Fabric, butterfly wound closure, 3/4"x3", 1"x3", spot bandage, 2"x3", knee&elbow, fingertip, knuckle Transparent Dressing, Wound Closure Strips Bandage PE skin color 3/4"x3", 1"x3", junior bandage, spot bandage, 2"x3", knee&elbow Battery-powered medical examination light, Penlight MOUTH TO MOUTH MASK, CPR FACE SHIELD Alcohol Prep Pad, Alcohol Swab Sticks, Antiseptic Wipes, Normal Saline Wipe Povidone-lodine Swab Stick Cleaning Wipe, Soap Wipe, BZK Wipe: Povidone-lodine Prep Pad, Emergency Obstetrical Kit, OB Kit Gauze Bandage, Bandage Elastic Emergency Blanket, Emergency Sleeping Bag, Foil Baby bunting Tongue Depressor Medical Scissors, Bandage Scissors, EMT Shears Kangzhu Cupping Set Pressure Cupping Set Cupping Set Saline Solution, Skin Wash Instant Ice Pack, Instant Cold Pack, Instant Hot Pack Wound Closure Strips, Wound Closure Device Chest Seal Non-Sterile Cotton Roll, Medium, Dental 40/50/6/Cs Non-sterile Cotton Ball, Sterile Cotton Ball, Absorbent Cotton Ball Dressing, Compression Silver Alginate Dressing, Calcium Alginate with Silver (Ag) Dressing, Silver Calcium Alginate Dressing Finger Splint, Flat Splint, Wrist and Arm Flat Splint, SPLINT

    Establishment Types

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