BEUDAMED
    FDA Registration Active 🇨🇳 China

    KOSSEL MEDTECH (SUZHOU) CO., LTD.

    Reg #: 3014390222 · FEI: 3014390222 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    KOSSEL MEDTECH (SUZHOU) CO., LTD.
    Registration Number
    3014390222
    FEI Number
    3014390222
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    BLDG 6, No.8 Jinfeng Road, Suzhou New District, 215163 P.R. China
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K211349

    Owner / Operator

    Firm Name
    Kossel Medtech (Suzhou) Co., Ltd.
    Operator Number
    10061920
    Address
    BLDG 6, No.8 Jinfeng Road, Suzhou New District, 215163 P.R. China
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215163
    Country
    CN
    Correspondent
    Zane Wang

    US Agent

    Business Name
    PUREVISION AI, INC (DBA PURE GLOBAL)
    Contact Name
    Bryan Wong
    Address
    111 Town Square Pl, Ste 1203
    City
    Jersey City
    State
    NJ
    ZIP
    07310
    Country
    US
    Email
    [email protected]
    Phone
    888 7681688

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Syringe, Balloon Inflation, Exempt PTM
    General Use Pneumatic Tourniquet QGX

    Proprietary Names

    Selebrek PTCA Balloon Dilatation Catheter Falspeed PTA Balloon Dilatation Catheter Selethru PTCA Balloon Dilatation Catheter Selepump Inflation Device Falexpand HP PTA Balloon Dilatation Catheter Selethru NC PTCA Balloon Dilatation Catheter Selestem Radial Artery Tourniquet

    Establishment Types

    Manufacture Medical Device