BEUDAMED
    FDA Registration Active 🇨🇳 China

    Arjo (Suzhou) Co., Ltd.

    Reg #: 3005619970 · FEI: 3005619970 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    50
    Establishment Types
    3
    Classifications
    2

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    Arjo (Suzhou) Co., Ltd.
    Registration Number
    3005619970
    FEI Number
    3005619970
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 158 Fangzhou Road, SIP, Suzhou, Jiangsu,
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K143438

    Owner / Operator

    Firm Name
    ARJOHUNTLEIGH AB
    Operator Number
    8010077
    Address
    Hans Michelsensgatan 10
    City
    Malmo
    State
    Skane
    Postal Code
    211 20
    Country
    SE

    US Agent

    Business Name
    Arjo Inc
    Contact Name
    Darren Demerritt
    Address
    2000 Center Drive, Suite D403
    City
    Hoffman Estates
    State
    IL
    ZIP
    60192
    Country
    US
    Email
    [email protected]
    Phone
    425 3089587

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW
    Mattress, Air Flotation, Alternating Pressure FNM

    Proprietary Names

    FLOWTRON ACS900 PUMP OPERATING ROOM (SUZHOU- MFR., POZNAN - COMPLAINTS) FLOWTRON ACS900 PUMP (SUZHOU - MFR., POZNAN - COMPLAINTS) BUBBLE PAD MATTRESS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ALPHA RESPONSE PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) NIMBUS 3 PUMP (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) BREEZE MATTRESS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ALPHA TRANCELL DELUXE PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS) ACER PORTABLE LATERAL ROTATION SYSTEM (POZNAN - SPEC.DEVELOPER & POZNAN - COMPLAINTS) BREEZE PUMP (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP SELECT PUMP (SUZHOU - MANUFACTURER & POZNAN - COMPLAINTS) THERAKAIR VISIO MATTRESS (POZNAN - COMPLAINTS) AURA CUSHION (SUZHOU - MFR & POZNAN - COMPLAINTS) FIRST STEP ALL IN ONE (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP SELECT MATTRESSES (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ALPHA RESPONSE MATTRESS (POZNAN - SPEC. DEVELOPER, POZNAN - COMPLAINTS) AUTOLOGIC MATTRESS (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) THERAKAIR VISIO PUMP (POZNAN - COMPLAINTS) NIMBUS 4 PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS) NIMBUS 4 MATTRESS ASSEMBLY RELIANT IS2 (SUZHOU - MFR & POZNAN - COMPLAINTS) PROFICARE (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) AURA PUMP (SUZHOU - MFR & POZNAN - COMPLAINTS) FIRST STEP CIRRUS OVERLAY (SUZHOU - MFR & POZNAN - COMPLAINTS) NIMBUS PRO MATTRESS (SUZHOU - MFR & POZNAN - COMPLAINTS) MAXXAIR ETS (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ATMOSAIR 9000AR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) NIMBUS 3 MATTRESS (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) AUTOLOGIC PUMP (SUZHOU - SPEC.DEV & POZNAN - COMPLAINTS) CITADEL CONTROL UNIT AND MATTRESS (SUZHOU - SPEC. DEVELOPER & MANUFACTURER, POZNAN - COMPLAINTS, POZNAN - FOREIGN EXP) ATMOSAIR (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP PLUS (SUZHOU - MFR & POZNAN - COMPLAINTS) ATMOSAIR 9000A (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) ATMOSAIR APOD (POZNAN - SPEC. DEVELOPER & POZNAN - COMPLAINTS) FIRST STEP SELECT HD (SUZHOU - SPEC. DEVELOPER & POZNAN - COMPLAINTS) AURALIS PUMP (SUZHOU - MFR, POZNAN - MFR & COMPLAINTS) AURALIS MATTRESSES (SUZHOU - MFR, POZNAN - MFR & COMPLAINTS) ATMOSAIR VELARIS MATTRESSES (POZNAN – MFR, POZNAN – COMPLAINTS) ATMOSAIR VELARIS PUMP (SUZHOU – MFR, POZNAN – COMPLAINTS) CAYLIS PUMP (SUZHOU – MFR, POZNAN – COMPLAINTS); CAYLIS MATTRESSES (SUZHOU – MFR, POZNAN – COMPLAINTS) FLOWTRON ACS800 PUMP OPERATING ROOM VARIANT (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) FLOWTRON ACS800 PUMP (SUZHOU - SPEC. DEVELOPER, POZNAN - COMPLAINTS) TRI PULSE GARMENTS TRP10, TRP20, TRP30, TRP40 & TRP60L (POZNAN - SPEC. DEV., MFR. & COMPLAINTS) Hydroven 12 Garments (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS, POZNAN - CONTRACT MFR) Hydroven 12 Pump (HUNTLEIGH HEALTHCARE - SPEC. DEVELOPER & COMPLAINTS,SUZHOU- CONTRACT MFR) WoundExpress Garment WoundExpress Pump FLOWTRON UNIVERSAL AC600 PUMP (POZNAN - COMPLAINTS) FLOWTRON UNIVERSAL AC600OR PUMP (POZNAN - COMPLAINTS) HYDROVEN GARMENTS (POZNAN - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE) HYDROVEN 3 PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE) HYDROVEN FPR PUMP (SUZHOU - CONTRACT MFR), SPEC. DEVELOPER AND COMPLAINTS (HUNTLEIGH HEALTHCARE)

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)