BEUDAMED
    FDA Registration Active 🇨🇳 China

    Sterilance Medical (Suzhou) Inc.

    Reg #: 3014649053 · FEI: 3014649053 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    89
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    Sterilance Medical (Suzhou) Inc.
    Registration Number
    3014649053
    FEI Number
    3014649053
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.168 PuTuoShan Road, New District
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221521

    Owner / Operator

    Firm Name
    Sterilance Medical (Suzhou) Inc.
    Operator Number
    9070037
    Address
    No.168 PuTuoShan Road, New District
    City
    SUZHOU
    State
    Jiangsu
    Postal Code
    215133
    Country
    CN

    US Agent

    Business Name
    REGULATORY INSIGHT, INC.
    Contact Name
    KEVIN WALLS
    Address
    33 Golden Eagle Lane, --
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Blade, Scalpel GES
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Handle, Scalpel GDZ
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Pack, Hot Or Cold, Reusable IME
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Scalpel, One-Piece GDX
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Blades Skin Graft Knife Blade Blade Arm Achilles Stitch Cutter Asurity Skin Graft Gouge Standard SS Standard CS Disposable surgical blades Safety Blades Index Asurity MEDLINE Adjustable Depth Safety Lancets Press2 Press Flex3 Press Plus Safety Pressure Activated Lancets Press2 Plus SENSILANCE™ BUTTON ACTIVATED SAFETY LANCETS Lite3 Embrace® Pressure Activated Safety Lancets UltraLANCE™ Sterile Safety Lancets Index Asurity Safety Handle Twist Lancets Embrace® Blood Glucose Sterile Lancets OneTouch UltraSoft2 Soft KetoBM Sterilized Lancets suttersync™ Soft Disposable Blood Lancet WALG LANCETS Sinodraw® Soft Disposable Blood Lancet Disposable steel lancet Twist lancets PA Clix MiniCollect PIXIE ice bag SteriHeel 2 Blueline™ Heel Incision Safety Lancets Neoheel SteriHeel Plus SteriHeel Safety-Heel®Newborn Safety-Heel®Preemie MiniCollect® PIXIE Heel Incision Safety Lancet Heel Incision Device McKesson PREVENT® Heel Incision Devices NEWBORN Heel Plus OctaHeel KBMED™ Heel Incision Safety Lancet SteriLance Lancing Device LDE 4-AST LDE4 LDE4 AST LDE AST NanoSense OneStep LDE NANOSense™ Lancing Device suttersync™ Lancing Device Elite Lite4 Impress Pro Disposable safety lancet Elite Disposable safety lancet Elite Pro Elite Pro One-Care PRO Safety Lancets One-Care COMFORT Safety Lancets Impress LMP DIAGNOSTICS™ Disposable Safety Lancets Safety Protected blade System Index handle Scalpel Mini Disposable Scalpel Disposable Safety Scalpel Standard Mini Standard II Asurity Cartridge Safety I Standard I Soft Disposable Blood Lancet Easydrip Disposable Insulin Needle Softsense Soft Pro Onestep NANOSense™ Lancets Softsure Pro STERILANCE™ OneStep Lancets Softsure

    Establishment Types

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