BEUDAMED
    32 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Country: China × Clear all

    BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),

    FDA Enforcement
    Class I ·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025

    BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)

    FDA Enforcement
    Class I ·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025

    BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U

    FDA Enforcement
    Class I ·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025

    BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U

    FDA Enforcement
    Class I ·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025

    Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U

    FDA Enforcement
    Class I ·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025

    BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U

    FDA Enforcement
    Class I ·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025

    Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

    FDA Enforcement
    Class I ·Ongoing·Jiangsu Well Biotech Co.,Ltd.·October 19, 2022

    Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

    FDA Enforcement
    Class I ·Ongoing·DEWEI MEDICAL EQUIPMENT CO LTD·December 14, 2022

    GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 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 Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 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 Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025

    Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).

    FDA Enforcement
    Class I ·Completed·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD·June 9, 2021

    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type

    FDA Enforcement
    Class I ·Ongoing·Haimen Shengbang Laboratory Equipment Co. Ltd.·August 17, 2022

    Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

    FDA Enforcement
    Class I ·Completed·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD·June 9, 2021

    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1

    FDA Enforcement
    Class I ·Ongoing·Haimen Shengbang Laboratory Equipment Co. Ltd.·August 17, 2022

    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made

    FDA Enforcement
    Class I ·Ongoing·Haimen Shengbang Laboratory Equipment Co. Ltd.·August 17, 2022

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

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

    GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025

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

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025