BEUDAMED
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    Ankang dre cheng medical equipment CO., LTD

    Manufacturer
    🇨🇳 China

    ANHUI ARES MEDICAL TECHNOLOGY CO.,LTD.

    FDA registration
    ANHUI ARES MEDICAL TECHNOLOGY CO.,LTD.·28 products·🇨🇳 China

    Creatinine (CRE) Assay Kit (Enzymatic Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

    AutoScan-DS-EX Pro(H),A-IS Pro3,OS GOLDY,Capella M5,OS-300

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Shining 3D Tech Co., Ltd.·4 devices

    Skin Electrical Conductance Meters

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Qinhuangdao Huisianpu Medical Systems Inc·1 device

    TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.

    FDA Enforcement
    Class II ·Ongoing·Guangzhou Improve Medical Instruments Co., Ltd.·August 22, 2018

    Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare (Suzhou) Co., Ltd.·March 24, 2021

    Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

    FDA Enforcement
    Class II ·Ongoing·Philips Healthcare (Suzhou) Co., Ltd.·January 17, 2024

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Enforcement
    Class II ·Ongoing·Guangzhou Wondfo Biotech Co., Ltd.·August 22, 2018

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Enforcement
    Class II ·Ongoing·Guangzhou Wondfo Biotech Co., Ltd.·August 22, 2018

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Enforcement
    Class II ·Ongoing·Guangzhou Wondfo Biotech Co., Ltd.·August 22, 2018

    Diode Laser Hair Removal model: WLA-01

    FDA Enforcement
    Class II ·Ongoing·WINGDERM ELECTRO-OPTICS LTD.·December 11, 2024

    Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024

    Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Enforcement
    Class II ·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024