BEUDAMED
    FDA Registration Active 🇨🇳 China

    SUZHOU SUNMED CO., LTD

    Reg #: 3005533873 · FEI: 3005533873 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    37
    Establishment Types
    3
    Classifications
    28

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    Registration Details

    Registration Name
    SUZHOU SUNMED CO., LTD
    Registration Number
    3005533873
    FEI Number
    3005533873
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO.88 SHISHAN ROAD,
    City
    SUZHOU CITY Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K060832

    Owner / Operator

    Firm Name
    SUZHOU SUNMED CO., LTD
    Operator Number
    10046764
    Address
    NO.88 SHISHAN ROAD,
    City
    SUZHOU CITY
    State
    Jiangsu
    Postal Code
    215011
    Country
    CN
    Correspondent
    Irene Pang

    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
    Bedding, Disposable, Medical KME
    Shoe, Cast IPG
    Gauze / Sponge,Nonresorbable For External Use NAB
    Joint, Ankle, External Brace ITW
    Insoles, Medical KYS
    Band Or Belt, Pelvic Support ISR
    Splint, Hand, And Components ILH
    First Aid Kit Without Drug OHO
    Accessory, Surgical Apparel LYU
    Fiber, Medical, Absorbent FRL
    Dressing, Wound, Hydrophilic NAC
    Pack, Hot Or Cold, Disposable IMD
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Dressing, Wound, Drug FRO
    Bag, Ice KYR
    Orthosis, Limb Brace IQI
    Dispenser, Solid Medication NXB
    Disinfectant, Medical Devices LRJ
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Suit, Surgical FXO
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Accessories, Catheter KGZ
    Tape And Bandage, Adhesive KGX
    Finger Cot LZB
    Stocking, Medical Support (For General Medical Purposes) FQL
    Bandage, Elastic FQM
    Joint, Knee, External Brace ITQ
    Protector, Skin Pressure FMP

    Proprietary Names

    Emergency blanket; Fire blanket adjustable orthopedic knee braces post op shoe, heel wedge shoe, offloading shoe, soft night splint, hard night splint, cast shoe, shoe balancer Non-Adherent Pad Dressing Kit Ankle Support GEL TOE SEPERATOR, GEL BUNION GUARD ,GEL HEEL CUP, GEL CUSHIONS ,BUNION TOE SPREADER,HEEL LINERS Waist Support Arthritis gloves; Compress gloves First Aid Kit Gloves disposable face mask Absorbent gauze products First Aid Bandage Sterile Wound Plaster Wound Dressing; RTD Wound Dressing Cold And Hot Therapy Pack, Heat Pack RTD Wound Dressing; RTD Wound Dressing; DermaBlue Foam; Gentell Blue Foam Dressing; Vitale RTD Wound Dressing; CuraBlue Silver Foam Instant Cold Pack Shin Support,Thigh Support GEL CORN PROTECTORS, GEL TOE PROTECTOR, TOE BANDAGES, TOE WRAPS Pill Box Wipes Alcohol Pad Padded Splint Non-woven Swabs penrose tube Medical Adhesive Tape, Kineso Tape, Adhesive Sport Tape Finger Cot Compression Night Garment, Compression Day Garment, Compression Garment Socking Medical Bandage,Elastic Bandage, Tubular Bandage, Cohesive Bandage, P.O.P Bandage, Stockinette Bandage Wrist Band,Head Band Socks Palm Support,Wrist Support,Elbow Support,Knee Support GEL CALLUS REMOVERS, CORN REMOVER, Heel Ankle Protector GEL TOE SPACERS, CALLUS CUSHION, CALLUS REMOVER, CORN CUSHION, BUNION CUSHION, CORN REMOVER,

    Establishment Types

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