BEUDAMED
    FDA Registration Active 🇨🇳 China

    EMSRUN GROUP

    Reg #: 3012777736 · FEI: 3012777736 · Expires 2026
    View on FDA
    Products
    54
    Proprietary Names
    69
    Establishment Types
    2
    Classifications
    54

    Registration Details

    Registration Name
    EMSRUN GROUP
    Registration Number
    3012777736
    FEI Number
    3012777736
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8-7 Huide Road, Huishan Area
    City
    Wuxi Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K163162

    Owner / Operator

    Firm Name
    EMSRUN GROUP
    Operator Number
    10052960
    Address
    8-7 Huide Road, Huishan Area
    City
    Wuxi
    State
    Jiangsu
    Postal Code
    214000
    Country
    CN
    Correspondent
    Weifeng Li

    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
    Pack, Hot Or Cold, Reusable IME
    Pad, Eye HMP
    Bag, Urine Collecting, Ureterostomy EXG
    Operating Room Accessories Table Tray FWZ
    Disinfectant, Medical Devices LRJ
    Scissors, General, Surgical LRW
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Antistick MEG
    Mask, Oxygen, Low Concentration, Venturi BYF
    Forceps HTD
    Stethoscope, Manual LDE
    Chair And Table, Medical KMN
    Set, Administration, Intravascular FPA
    Mask, Oxygen BYG
    Oximeter DQA
    Band Or Belt, Pelvic Support ISR
    Dressing, Wound, Occlusive NAD
    Orthosis, Cervical IQK
    Stretcher, Hand-Carried FPP
    Adhesive Backed Thermal Skin Patches OMW
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Bedding, Disposable, Medical KME
    Bottle, Collection, Vacuum KDQ
    Pack, Hot Or Cold, Disposable IMD
    Toothbrush, Manual EFW
    Support, Patient Position CCX
    Splint, Traction HSP
    Catheter, Infusion JCY
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    First Aid Kit With Drug LRR
    Splint, Hand, And Components ILH
    Tourniquet, Nonpneumatic GAX
    Tube, Ear Suction JZF
    Bed, Manual FNJ
    Instrument, Manual, Surgical, General Use MDM
    Non-Surgical Gown OEA
    Airway, Nasopharyngeal BTQ
    First Aid Kit Without Drug OHO
    Airway, Oropharyngeal, Anesthesiology CAE
    Tape And Bandage, Adhesive KGX
    Gauze / Sponge,Nonresorbable For External Use NAB
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Lubricant, Patient KMJ
    Regulator, Pressure, Gas Cylinder CAN
    Accessory, Surgical Apparel LYU
    Bandage, Cast ITG
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Bandage, Elastic FQM
    Shield, Protective, Personnel KPY
    Orthosis, Truncal/Orthosis, Limb MRI
    Syringe, Piston FMF
    Needle, Aspiration And Injection, Disposable GAA
    Light, Surgical, Endoscopic FSW
    Light, Examination, Medical, Battery Powered KYT

    Proprietary Names

    ice pack sterile eye pad Dry Bag Operating table antiseptic wipes,cleansing wipes alcohol prep pad, soap wipes, povidone iodine prep pads,iodine cotton ball,iodine cottonbar,iodine cotton towel alcohol cotton ball wipes medical scissor Piston Syringe with Needle mouth to mouth mask forceps,tweezers Stethoscope church Trolly Infusion set CPR mask,breathing mask Fingertip Oximeter Pelvis belt Wound dressing,transparent wound dressing dressing chest seal cervical Collar vacuum mattress stretcher,spine board, Evacuation Chair Stretcher, traction splint soft Stretcher,Isolation stretcher,Stretcher platform, stair stretcher, folding Stretcher ambulance Stretcher,scoop stretcher,basket stretcher,multifunctional rescue stretcher Carbon Fiber Scoop Stretcher cooling gel sheet Hemostatic Dressing emergency sleeping bag, emergency blanket, body bag Manual suction pump compress/pack,heat pack Toothbrush extrication device aluminum mouldable splint IV catheter Goggle first aid kit WITH DRUG finger splint Tactical Tourniquet tourniquet suction tube Camping bed,Hospital bed Packaging pouch, self-sealed sterilization pouch Protective suit ISOLATION Gown Nasopharyngeal Airway first aid kit, TRAUMA KIT Airway adhesive bandage, Israel wound dressing wound closures tape dressing pad gauze swabs rolled gauze compressed gauze Burn Gel Burn Dressing Lubricating Jelly Oxygen cylinder,oxygen regulator, oxygen Flow meter face shield, life Hammer, emergency tent self adhesive elastic bandage/PBT Elastic Bandage,triangular bandage bar,stick,swab Tactical Bandage, elastic bandage, Constricting band FACE SHIELD head immobilizer Decompression needle Surgical light Pulse Oximeter LED Penlight

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device