BEUDAMED
    FDA Registration Active 🇨🇳 China

    Sichuan AST Medical Equipment Co., Ltd

    Reg #: 3008058406 · FEI: 3008058406 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    52
    Establishment Types
    3
    Classifications
    18

    Registration Details

    Registration Name
    Sichuan AST Medical Equipment Co., Ltd
    Registration Number
    3008058406
    FEI Number
    3008058406
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.58 ,Jin-Peng Road, C area, Luxian Industrial Park
    City
    Luzhou City Sichuan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K231750

    Owner / Operator

    Firm Name
    Sichuan AST Medical Equipment Co., Ltd
    Operator Number
    10030716
    Address
    No. 58, Jin-Peng Road, C area, Luxian Industrial Park
    City
    Luzhou City
    State
    Sichuan
    Postal Code
    646100
    Country
    CN
    Correspondent
    Michelle Chu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Accessories, Wheelchair KNO
    Wheelchair, Mechanical IOR
    Attachment, Commode, Wheelchair INB
    Crutch IPR
    Cover, Mattress (Medical Purposes) FMW
    Walker, Mechanical ITJ
    Components, Wheelchair KNN
    Footrest, Wheelchair IMM
    Stand, Infusion FOX
    Mask, Scavenging KHA
    Device, Fixation, Tracheal Tube CBH
    Strap, Head, Gas Mask BTK
    Chair, With Casters INM
    Adaptor, Hygiene ILS
    Mattress, Water, Temperature Regulated FOH
    Chair, Adjustable, Mechanical INN
    Non-Surgical Gown OEA
    Device, Anti-Tip, Wheelchair IMR

    Proprietary Names

    WHEELCHAIR ACCESSORIES MA012 Aluminum Wheelchair, MS019 Steel Wheelchair Commode chair (NRS185006, NRS185007, NRS185008) Crutches AST Model MA012 Rehab Wheelchair AST Model MS019 Rehab Wheelchair mattress 700-920, 700-921, 700-922, 700-927, 700-928, 700-929, 700-932, 700-932PB, 700-935, 700-935BK, 700-935CR, 700-938, MD700935BK, MD700935BL, MD700935GN) 700-957, 700-959, 700-959E, 700-961, 700-977, 700-979, 700-920PR, MD700920BK, MD700920BL, MD700920PR, MD700929BL, Rollator (RLA6BGF, RLA8BGF, RLA6BG, RLA8BG, RLA6BK, RLA8BK, RLA6BLF, RLA8BLF, RLA6BL, RLA8BL, 700-917, 700-917BK, Mechanical Walker Manual Wheelchair (MASY23) wheelchair components LIMB SUPPORT IV Pole Medical Mask Medical Fixation Strap Belt (A1:Catheter fixation (pediatric)/A2:Indwelling needle fixation/A3:Indwelling needle, central venous catheter fixation/B1:Peripheral IV catheter, indwelling needle fixation/B2:Peripheral IV catheter, indwelling needle fixation/B3:Central venous catheter fixation double lumen)/C1:Catheter and drainage tube fixation/ D2:Peripheral venous catheter fixation patch(Thin film type)/L1:Nasogastric tube,nasogastric tube fixed (single tube)/ C6:Central venous catheter tracheal intubation fixed/D1:Peripheral venous catheter fixation patch/ L2:Nasogastric tube, nasogastric tube fixed (double tube)/ L4:Nasogastric tube,nasogastric tube fixed (pediatric double tube)) C4:Catheter and drainage tube fixation/C5:Central venous catheter tracheal intubation fixed/ A5:Retention needle fixation (Y type)/A6:Indwelling needle, peripheral IV catheter fixation/A7:Indwelling needle, C2:Catheter and drainage tube fixation (pediatric)/C3:Central venous catheter tracheal intubation fixed/ L3:Nasogastric tube, nasogastric tube fixed (pediatric single tube)/ central venous catheter fixation/A4:Indwelling needle, peripheral IV catheter fixation/ Gas cutting fixture(XW2023403)} Gas cutting device{Gas cut fixed Strap(XW2023401), Tracheal intubation fixation(XW2023402), Head strap hook(XW2023904), CPAP mask silicone pad(XW2023905)) ResMed AirFit F20 Headgear(XW2023103), Dream Wear Headgear(XW2023104), Philips Respironics Wisp Headgear(XW2023105), XW2023007/XW2023008/XW2023009), P10 Nasal pillow headband(XW2023101), ResMed AirFit N20 Headgear(XW2023102), Philips Respironics Fit Life Headgear(XW2023106), Philips Respironics Amara view headgear(XW2023107), CPAP head strap anti-mark pad(XW2023901), Non-slip sleeve for nasal mask(XW2023902), Mask hose protector(XW2023903), Nuance Pro Headgear(XW2023108), Fisher & Paykel Simplus Headgear(XW2023109), Fisher & Paykel Vitera Headgear(XW2023110), Head strap and accessories(CPAP Strap(XW2023001/XW2023002/XW2023003),CPAP HEADGEAR(XW2023004/XW2023005/XW2023006/ Chair with castor (CLN400-20, TR-1200-FR, TR-1200-JB, TR-1200-PP, TR-1400-FR, TR-1400-JB, TR-1400-PP, TR-1600-FR, TR-1600-JB, TR-1600-PP, TR-1800-FR, TR-1800-JB, TR-1800-PP) Guardian Wheelchair, Medline Wheelchair, Mechanical - IOR REHAB SHOWER, BATHMAT Gel overylay Full Tilt and Recliner PROTECTIVE CLOTHING AST-90A ANTI TIPPERS 14¿ pediatric wheelchair (MS011-1) 22¿ heavy duty wheelchair (MS006-2) 18¿ reclining wheelchair (MS008-1) 28¿ bariatric wheelchair (MS010-1) 18¿ standard wheelchair (MS005-4)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device