BEUDAMED
    FDA Registration Active 🇨🇳 China

    XINKANG MEDICAL INSTRUMENT CO. LTD.

    Reg #: 3017953522 · FEI: 3017953522 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    XINKANG MEDICAL INSTRUMENT CO. LTD.
    Registration Number
    3017953522
    FEI Number
    3017953522
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    808, Building 6, Hengda Fashion Valley Building (East District), Fulong Road, Shanghenglang Community, Dalang Street, Longhua District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K201360

    Owner / Operator

    Firm Name
    Xinkang Medical Instrument Co. Ltd.
    Operator Number
    10078983
    Address
    808, Building 6, Hengda Fashion Valley Building (East District), Fulong Road, Shanghenglang Community, Dalang Street, Longhua District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518100
    Country
    CN
    Correspondent
    Changsheng Xu

    Products

    Device Name Product Code
    Oximeter DQA
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA

    Proprietary Names

    Xinkang, HP 8Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSNS2 Xinkang, Spacelabs 10Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSNY1 Xinkang, HP 8Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSNY2 Xinkang, NELLCOR 9Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSNY3 Xinkang, BCI 9Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF1 Xinkang, NELLCOR 9Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSIS3 Xinkang, BCI 9Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSAF1 Xinkang, Nellcor 9pin Oximax Disposable Adult Blue Sponge Spo2 Sensor, model: XDBS Xinkang, NELLCOR 14Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSAF2 Xinkang, Mindray T5 7Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAS4 Xinkang, NELLCOR 14Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAS2 Xinkang, Mindray T5 7Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF4 Xinkang, Spacelabs 10Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSIS1 Xinkang, GE2500 11Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSNY4 Xinakng, Nellcor 9pin Oximax Disposable Adult Non-woven Spo2 Sensor, model: XDAN Xinkang, HP 8Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAE2 Xinkang, BCI 9Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSPS1 Xinkang, GE2500 11Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSIS4 Xinkang, Spacelabs 10Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSNS1 Xinkang, BCI 9Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAS1 Xinkang, GE2500 11Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSNS4 Xinakng, Nellcor 9pin Oximax Disposable Adult L type Non-woven Spo2 Sensor, model: XDBN Xinkang, GE2500 11Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAE4 Xinkang, HP 8Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSIS2 Xinkang, NELLCOR 9Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAE3 Xinkang, Mindray 6Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSAF3 Xinkang, Mindray 6Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAS3 Xinkang, Mindray 6Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF3 Xinkang, Mindray 6Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSPS3 Xinakng, Nellcor 9pin Oximax Disposable Pediatric Non-woven Spo2 Sensor, model: XDPN Xinkang, Spacelabs 10Pin Reusable Adult Silicone Soft Spo2 Sensor, model: XSAE1 Xinkang, Mindray T5 7Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSAF4 Xinkang, NELLCOR 14Pin Reusable Pediatric Finger Clip Spo2 Sensor, model: XSPF2 Xinkang, NELLCOR 9Pin Reusable Adult Finger Clip Spo2 Sensor, model: XSNS3 Xinkang, Mindray T5 7Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSPS4 Xinkang, NELLCOR 14Pin Reusable Pediatric Silicone Soft Spo2 Sensor, model: XSPS2 ECG Cables and Leadwires, Model: G2202B10A, G2202C10A, G2202S10A, E2101C5A, E2101C3A, E2101S3A, E2101S5A

    Establishment Types

    Manufacture Medical Device