BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.

    Reg #: 3013528571 · FEI: 3013528571 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    48
    Establishment Types
    2
    Classifications
    10

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    Registration Details

    Registration Name
    SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3013528571
    FEI Number
    3013528571
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Floor 13th, HTM Building, Ganli Road, Longgang District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232580

    Owner / Operator

    Firm Name
    Shenzhen Insighters Medical Technology Co., Ltd.
    Operator Number
    10053495
    Address
    The 13th floor of Hengtemei Building,Ganli Road No. 3
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518000
    Country
    CN
    Correspondent
    Baohong Fang

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Airway, Oropharyngeal, Anesthesiology CAE
    Instrument, Ent Manual Surgical LRC
    Laryngoscope, Non-Rigid CAL
    Medical Device Data System OUG
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Bronchoscope (Flexible Or Rigid) EOQ
    Stylet, Tracheal Tube BSR
    Connector, Airway (Extension) BZA
    Laryngoscope, Rigid CCW
    Catheters, Suction, Tracheobronchial BSY

    Proprietary Names

    Laryngeal Mask Airway Model: iS-LMA-A30, iS-LMA-A40, S-LMA-A50 Model:iSLMAVA15Y 1.5#;iSLMAVA20Y 2#;iSLMAVA25Y 2.5#;iSLMAVA30Y 3#;iSLMAVA40Y 4#;iSLMAVA50Y 5# Model:iSLMAC10 1#;iSLMAC15 1.5#;iSLMAC20 2#;iSLMAC25 2.5#;iSLMAC30 3#;iSLMAC40 4#;iSLMAC50 5# Disposable Laryngeal Mask Airway Model:iSLMAVB15Y 1.5#;iSLMAVB20Y 2#;iSLMAVB25Y 2.5#;iSLMAVB30Y 3#;iSLMAVB40Y 4#;iSLMAVB50Y 5# Model:iSLMAA10 1#;iSLMAA15 1.5#;iSLMAA20 2#;iSLMAA25 2.5#;iSLMAA30 3#;iSLMAA40 4#;iSLMAA50 5# Model:iSLMAVC15Y 1.5#;iSLMAVC20Y 2#;iSLMAVC25Y 2.5#;iSLMAVC30Y 3#;iSLMAVC40Y 4#;iSLMAVC50Y 5# Single-use Video Laryngeal Mask Airway Model:iSLMAB10 1#;iSLMAB15 1.5#;iSLMAB20 2#;iSLMAB25 2.5#;iSLMAB30 3#;iSLMAB40 4#;iSLMAB50 5# Disposable Blade Video Flexible Laryngoscope,Model: iS3-C; iS3-FN2; iS3-F; iS3-C4; iS3-C5; iS3-C6; iS3-F2; iS3-F3;iS-B01 Insight Workstation, Model: iS-PF1, iS-PF2 Insight Workstation Accessory-Wireless Module, Connection Cable,Power Adapter Insight Workstation Accessory-Trolley:iS-TC1,iS-TC2 Disposable Endobronchial Blocker Tube:5Fr;7Fr;9Fr Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5/2.6 Single-use Flexible Video Bronchoscope Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2 Insighters™ Insight Workstation iS-PF 1 Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6/3 Stylet: insight ST1 Tracheal Tube Adapter Model: QT01 Video Laryngoscope,Model: iS3-L Video Rigid Laryngoscope, Model: iS3-R Video Laryngoscope, Model: insight iS6 Video Laryngoscope, Model: insight iS2 Single-Use Laryngoscope Blade,Model: i6-SS;i6-S;i6-M;i6-L;SS;S;M;L Video Laryngoscope Accessory-Handle (iS6-H) Video Laryngoscope Accessory-Handle (iS3) Video Laryngoscop Accessory-3.5 inch Host (iS6-M) Video Laryngoscope, Model: iS-NEO Video Laryngoscope Accessory-Power Adapter Video Laryngoscope Accessory- 3.5 inch Host (iS3) Video Laryngoscope Accessory-Handle (NEO-0/NEO-1) Single-Use Laryngoscope Blade,Model: MAC1 SS;MAC2 S;MAC3 M;MAC4 L;SS-Pro;S-Pro;M-Pro;L-Pro;MAC3;MAC4 Disposable Closed Suction Catheter Long-acting Type: 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr Child Type: 6Fr,8Fr Standard Type: 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr Disposable Suction Catheter,Model:iSKX06 6Fr;iSKX08 8Fr;iSKX10 10Fr;iSKX12 12Fr;iSKX14 14Fr;iSKX16 16Fr Disposable Double Lumen Endobronchial Tube (Visible Right Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) Disposable Double Lumen Endobronchial Tube (Visible Right Type B: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) Disposable Double Lumen Endobronchial Tube (Ordinary Left Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) Disposable Double Lumen Endobronchial Tube (Visible Left Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) Disposable Double Lumen Endobronchial Tube (Ordinary Right Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) Disposable Double Lumen Endobronchial Tube (Visible Left Type B: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device