BEUDAMED
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    Jiangsu Hitec Medical Co., Ltd

    Manufacturer
    🇨🇳 China

    HITEC MEDICAL CO., LTD

    FDA registration
    HITEC MEDICAL CO., LTD·17 products·🇨🇳 China

    Arazy Group GmbH

    Authorized representative
    🇩🇪 Germany·30 Manufacturers·739 Devices

    Shanghai International Holding Corp. GmbH(Europe)

    Authorized representative
    🇩🇪 Germany·637 Manufacturers·33064 Devices

    TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·November 9, 2016

    TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·September 8, 2016

    GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems

    FDA Recall
    Terminated ·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018

    GE Carestation 30 anesthesia systems

    FDA Recall
    Terminated ·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018

    GE 9100c NXT anesthesia systems

    FDA Recall
    Terminated ·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018

    F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code MHX·September 8, 2023

    GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

    GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

    GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

    GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

    GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·November 14, 2025

    GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

    GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

    GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025

    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002

    FDA Recall
    Open, Classified ·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·November 14, 2025