BEUDAMED
    FDA Registration Active 🇨🇳 China

    SUZHOU ACMED IMPORT & EXPORT CO., LTD.

    Reg #: 3006538822 · FEI: 3006538822 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    27

    Registration Details

    Registration Name
    SUZHOU ACMED IMPORT & EXPORT CO., LTD.
    Registration Number
    3006538822
    FEI Number
    3006538822
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    436 Changjiang Road, 2-10016
    City
    SUZHOU Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K082863

    Owner / Operator

    Firm Name
    SUZHOU ACMED IMPORT & EXPORT CO., LTD.
    Operator Number
    10025772
    Address
    436 Changjiang Road,, 2-10016
    City
    SUZHOU
    State
    Jiangsu
    Postal Code
    215011
    Country
    CN
    Correspondent
    Mark Ho

    US Agent

    Business Name
    Sun Luna Star LLC
    Contact Name
    Anna Sun
    Address
    6706 N Royce Ln
    City
    Van Nuys
    State
    CA
    ZIP
    91411
    Country
    US
    Email
    [email protected]
    Phone
    626 2005096

    Products

    Device Name Product Code
    Instrument, Surgical, Disposable KDC
    Sling, Arm ILI
    Gauze / Sponge,Nonresorbable For External Use NAB
    Speculum, Vaginal, Nonmetal HIB
    Bedding, Disposable, Medical KME
    Tubing, Noninvasive GAZ
    Accessories, Cleaning Brushes, For Endoscope MNL
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Mask, Gas, Anesthetic BSJ
    Dressing, Wound, Occlusive NAD
    Tubes, Gastrointestinal (And Accessories) KNT
    Gown, Surgical FYA
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Cover, Shoe, Operating-Room FXP
    Basin, Emesis FNY
    Fiber, Medical, Absorbent FRL
    Stocking, Medical Support (For General Medical Purposes) FQL
    Scissors, Umbilical HDJ
    Catheter, Continuous Irrigation GBQ
    Drape, Surgical, Antimicrobial KKX
    Syringe, Irrigating (Non Dental) KYZ
    Clamp, Surgical, General & Plastic Surgery GDJ
    Forceps, General & Plastic Surgery GEN
    Operating Room Accessories Table Tray FWZ
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Bandage, Elastic FQM
    Accessory, Surgical Apparel LYU

    Proprietary Names

    Triangular Bandage BORDER GAUZE SPONGES; COTTON; NON-WOVEN VAGINAL SPECULUMS BEDDING, DISPOSABLE, MEDICAL TUBING, NONINVASIVE ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE GAUZE; LAP AND VAGINAL SPONGES DISPOSABLE FACE MASK Sterile hydrocolloid dressing Enteral Delivery Pump Bag Set Enteral Feeding Gravity Bag Set Enteral Delivery Pump Set; Enteral Delivery Pump Bag Set;Enteral Feeding Gravity Bag Set Enteral Delivery Pump Set SURGICAL GOWNS APPLICATOR, ABSORBENT TIPPED, NON-STERILE SHOE COVER, TERRY TREADS; SLIPPER S BASIN, EMESIS SURGICAL TOWEL COTTON; STOCKINETTE Umbilical Cord Clamp Cutter CATHETER, CONTINUOUS IRRIGATION SURGICAL DRAPE BULB; EAR SYRINGE; IRRIGATION TOWEL CLAMP FORCEPS SHEETS-DRAPES; STAND & EQUIPMENT COVERS URINARY DRAINAGE BAGS AND URINARY LEG BANDAGE; ELASTIC; PREM-WEAVE; ULTRA-WEAVE; COMPRESS BANDAGE; COMPRESS GAUZE BANDAGE, KRINKLE GAUZE ROLL PATIENT DRAPES

    Establishment Types

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