BEUDAMED
    FDA Registration Active 🇨🇳 China

    Philips Ultrasound (Shanghai) Co., Ltd

    Reg #: 3005403518 · FEI: 3005403518 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    167
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Philips Ultrasound (Shanghai) Co., Ltd
    Registration Number
    3005403518
    FEI Number
    3005403518
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 5, 3000 Longdong Boulevard, Suite 102, Suite 203, Suite 702
    City
    SHANGHAI
    Country
    CN

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Automated Radiological Image Processing Software QIH
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    C6-2 C5-1 C9-3v S5-1 CX30 Diagnostic Ultrasound System L15-7io C10-3v CX50 Diagnostic Ultrasound System S8-3 D5cwc D2cwc S12-4 L12-5 50 C9-4v C9-3io S4-2 X7-2t C8-5 L12-3 LAP L9-5 L12-4 V6-2 S4-1 ClearVue 550 Diagnostic Ultrasound System ClearVue 650 Diagnostic Ultrasound System ClearVue 350 Diagnostic Ultrasound System 3D9-3v C5-2 ClearVue 580 Diagnostic Ultrasound System EPIQ 7G Diagnostic Ultrasound System EPIQ Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System V6-2; V9-2; VL13-5 eL18-4; eL18-4 EMT L12-3; L12-3ERGO D2tcd; D5cwc L12-5; L15-7io; L18-5 S4-2; S5-1 EPIQ Elite Diagnostic Ultrasound System C10-4ec; D2cwc EPIQ CVx Diagnostic Ultrasound System EPIQ 7W Diagnostic Ultrasound System EPIQ 7C Diagnostic Ultrasound System X5-1; X6-1; X7-2; X7-2t ; X8-2t; XL14-3 S7-3t; S8-3;S8-3t; S9-2 EPIQ 5G Diagnostic Ultrasound System EPIQ 5W Diagnostic Ultrasound System mC7-2; mC12-3 C5-1; C6-2; C8-5; C9-2; C10-3v EPIQ CVxi Diagnostic Ultrasound System EPIQ 5 Diagnostic Ultrasound System ClearVue 850 Diagnostic Ultrasound System L12-5 iU22 Ultrasound System Affiniti 50 Diagnostic Ultrasound System S7-3t Affiniti 70 Diagnostic Ultrasound System X7-2 VL13-5 L18-5 X5-1 BP10-5ec C10-4ec X6-1 D2tcd C9-2 Affiniti 30 Diagnostic Ultrasound System 5C2A Curved Linear Array Transducer 8V3A Sector Transducer 8EC4A Curved Array Transducer 12L5A Linear Array Transduce 4V2A Sector Transducer 12L5A Linear Array Transducer 9MC3 Curved Array Transducer Affiniti 70G Diagnostic Ultrasound System S8-3t Affiniti 50C Diagnostic Ultrasound System Affiniti 70W Diagnostic Ultrasound System S9-2 X8-2ti eL18-4 Affiniti 50G Diagnostic Ultrasound System Affiniti 50W Diagnostic Ultrasound System X8-2t Affiniti 70C Diagnostic Ultrasound System XL14-3 iU22 Diagnostic Ultrasound System S3 Sparq Diagnostic Ultrasound System HD11 Diagnostic Ultrasound System C6-3 V8-4 L9-3 Flash Ultrasound System 5100 Point of Care D2 TC L9-5 LAP C9-5ec T6H S7-2omni T6207 C9-4 S3-1 D2 CW iE33 Diagnostic Ultrasound System L12-5 50mm L11-3 L8-4 L17-5 C8-4v L12-5 38mm EPIQ Elite W Diagnostic Ultrasound System L12-3 ERGO mC7-2 V9-2 X5-1c S5-2 HD15 Diagnostic Ultrasound System S7-2omnni EPIQ 7 Ultrasound System EPIQ CVx Ultrasound System EPIQ 7 Diamond Select Ultrasound System EPIQ 7W Ultrasound System EPIQ 5 Ultrasound System EPIQ Series Diagnostic Ultrasound System Transducer mL26-8 EPIQ 7 Circular Edition Ultrasound System EPIQ 5 Diamond Select Ultrasound System EPIQ CVx Circular Edition Ultrasound System EPIQ CVxi Ultrasound System EPIQ 5 Circular Edition Ultrasound System EPIQ 5W Ultrasound System EPIQ Elite Circular Edition Ultrasound System C9-4ec 21373B (C5040) EnVisor Diagnostic Ultrasound System 21350A (S8) 21475A 21369A (Omni II) 21221B (C1914C) 21330A (S4) 21359A (L7535) 21321A (C3540) 21390A (15-61) 21223B (D5014V) 21380A (S12) 21422A 21360A (L5035) 21228B (D1914V) S4 L10-4lap CX50 Diamond Select Diagnostic Ultrasound System Sparq Diamond Select Diagnostic Ultrasound System CX50 Circular Edition Diagnostic Ultrasound System Sparq Circular Edition Diagnostic Ultrasound System InnoSight Diagnostic Ultrasound System Transducers: S4-2, C9-4v, L12-4, C6-2 3D8-4 C5-2 (21426A) S8-3 (21750A) S7-2omni (21778A) 3D6-2 PA4-2 (21422A) T6H (21378A) S7-3t (21781A) S3-1 (21711A) S12-4 (21780A) C8-4 (21437A)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)