BEUDAMED
    FDA Registration Active 🇨🇳 China

    LAERDAL MEDICAL (SUZHOU) CO., LTD.

    Reg #: 3004993040 · FEI: 3004993040 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    32
    Establishment Types
    2
    Classifications
    12

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    Registration Details

    Registration Name
    LAERDAL MEDICAL (SUZHOU) CO., LTD.
    Registration Number
    3004993040
    FEI Number
    3004993040
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO.19 BLDG., HUOJU RD., SCIENCE & TECHNOLOGY IND. PARK
    City
    215009 SUZHOU JIANGSU PROVINCE
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K861401

    Owner / Operator

    Firm Name
    LAERDAL MEDICAL A/S
    Operator Number
    9038993
    Address
    Tanke Svilandsgate 30, --
    City
    Stavanger
    State
    Rogaland
    Postal Code
    4007
    Country
    NO

    US Agent

    Business Name
    Laerdal Medical Corporation
    Contact Name
    Carl Narvesen
    Address
    167 MYERS CORNERS RD., --
    City
    Wappingers Falls
    State
    NY
    ZIP
    12590
    Country
    US
    Email
    [email protected]
    Phone
    845 2455201

    Products

    Device Name Product Code
    Valve, Non-Rebreathing CBP
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Mask, Oxygen, Non-Rebreathing KGB
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Device, Fixation, Tracheal Tube CBH
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Mask, Oxygen BYG
    Orthosis, Cervical IQK
    Syringe, Irrigating (Non Dental) KYZ
    Orthosis, Truncal/Orthosis, Limb MRI

    Proprietary Names

    LAERDAL POCKET MASK American Red Cross Pocket Mask The BAG PEEP Valve The BAG The BAG Manometer Laerdal Face Shield Laerdal Face Shield Key Ring Resusci Patient Face Shield American Red Cross Face Shield Laerdal Suction Unit (LSU) Laerdal Paediatric Pocket Mask Thomas Select Tube Holder - Adult THOMAS ENDOTRACHEAL TUBE HOLDER Thomas Tube Holder Pediatric Thomas Tube Holder Adult Laerdal Compact Suction Unit 4 (LCSU 4) Newborn Mask Snap Design Laerdal Silicone Mask The BAG Mask STIFNECK SELECT STIFNECK PEDI-SELECT Laerdal Silicone Resuscitator (LSR) V-VAC Manual Suction Unit NeoNatalie Suction Penguin Newborn Suction Penguin Suction Device Penguin Irrigating Syringe Sta-Blocks SpeedBlocks Stifneck NeoNatalie Resuscitator NeoNatalie Complete Kit

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device