BEUDAMED
    FDA Registration Active 🇨🇳 China

    ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD

    Reg #: 3003781173 · FEI: 3003781173 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    120
    Establishment Types
    2
    Classifications
    25

    Registration Details

    Registration Name
    ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD
    Registration Number
    3003781173
    FEI Number
    3003781173
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No 4 and No 8 Plants 9 Shenghui South Road, Nantou Town
    City
    Zhongshan City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K091272

    Owner / Operator

    Firm Name
    Zhongshan A&E Machinery Industry Co., LTD
    Operator Number
    10049449
    Address
    No 4 and No 8 Plants 9 Shenghui South Rd, Nantou Town
    City
    Zhongshan City
    State
    Guangdong
    Postal Code
    510000
    Country
    CN

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF
    Component, Traction, Non-Invasive KQZ
    Instrument, Manual, Surgical, General Use MDM
    Chair, With Casters INM
    Bed, Ac-Powered Adjustable Hospital FNL
    Walker, Mechanical ITJ
    Bariatric Bed OSI
    Cane, Safety Walk KHY
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Tray, Surgical, Instrument FSM
    Exerciser, Non-Measuring ION
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Halter, Head, Traction HSS
    Wheelchair, Mechanical IOR
    Chair And Table, Medical KMN
    Bed, Manual FNJ
    Adaptor, Hygiene ILS
    Aid, Transfer IKX
    Lift, Patient, Non-Ac-Powered FSA
    Stand, Infusion FOX
    Tips And Pads, Cane, Crutch And Walker INP
    Stool, Operating-Room FZM
    Crutch IPR
    Cane IPS
    Chair, Blood Donor FML

    Proprietary Names

    NEB-U-TYKE TRAIN DISPLAY RESERVOIR TUBE FOR NEB SPEEDST ACCESSORY KIT (PEN,STAR,HEART) NEB-U-TYKE RR TRAIN FILTER CAPS NEB-U-TYKE TRAIN FILTER CAPS FOR EV NEB FILTER FOR NEB PENGUIN & EV NEB-U-TYKE SPEEDSTER REPL FILTER FOR NEB-A-DOODLE NEB-U-TYKE NEB-A-DOODLE NEB-U-TYKE IC - PENGUIN RPLCMT BUMPER NEB-U-TYKE TRAIN FILTER PACK FOR NEB SPEEDSTER NEBULIZER CUP EACH FILTER PK FOR NEB-U-TYKE TRAIN CABINET FILTER FOR OPTIUM NEB-U-TYKE RACETRACK DISPLAY FILTER CAP FOR NEB-A-DOODLE DRAWING BRD FOR NEB-A-DOODLE NEB-U-TYKE IGLOO DISPLAY NEB-U-LITE EV 12/CS DUKAL Electric Perfect Leg Stretcher RAIL CROSSBRACE KNOBS 6/CS LIBERTY CROSSBARS (BEIGE) CROSSBAR BED UNIVERSAL CHROME BED RAILS FULL TELE UNIV CHRM REPLACEMENT CROSSBRACE SLEEVES BED RAILS LBTY QUARTER RAIL HI REPLC KNOB FOR GF6650A-1 RAILS STANDARD GLIDE BRAKES WHEELS 5 FXD BARIATRIC WALKERS WHEELS 5 AUTO-STOP 1 WKRS WALKR FOLD DUAL REL X-WD W/WHL UPRISE ONYX SIN RELEASE WALKER WHEELS 5 FXD FOR 1 WALKERS WALKER DUAL REL X-WD W/5 WHEEL 4" EXTENSION LEGS LUMEX DUAL RELEASE 1" JUNIOR GLIDE TIPS FXD WHEEL 5 W/ EXT 1 WLKRS UPRISE ONYX KD SN RELEAS WLKR WALKER FOLD SING REL ADLT WHEELS 3 FXD FOR 1 WALKERS WALKER W/5 WHLSDUAL REL 4/CS 3" SWIVEL WHEELS WALKER FOLD DUAL REL ADLT WHEELS 5 SWVL FOR 1 WKRS WALKER FOLD DUAL REL X-WD REPL LEG F/1" WALKERS & BATH Bariatric bed SUCTION RUBBER FEET FOR 800 EV NUT FLTR FOR VACUTEC 800 EV2 REPLACEMENT BOTTLE HOLDER EV2 SUCTION TUBE FOR 800 EV2 COLLECTION BOTTLE FOR 800 EV2 FILTERS FOR VACUTEC 800 EV2 REPLACMENT HANDLE FOR 800 EV2 ASPIRATOR VACUTEC 800 EV2 CONNECTION TUBING FOR 800 EV2 REGULATOR ASSEMBLY FOR 800 EV2 ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD. INSTRUMENT TABLE MAYO TYPE TRACTION SET OVERDOOR TRACTION VYL WTR WT BAG 20 LB. HEAD HALTER UNIVERSAL BACK UPH,BLK NYLON 30W-PMT XD ARMS,DETACH DSK - PMT XD ANTI-TIPPER PR, PARAMOUNT XD BACK UPH,BLK NYLON 26W-PMT XD ARM PAD, DSK - PMT XD MEDICHOICE BARI WC 26W DSK SWF WHL LOCK,PUSH TO LOCK-PMT XD LEGREST, COMPLETE - PMT XD GRIP(10EACH) PMT XD AXLE,NUT&WASHER(10EA) PMT XD ANTI-FOLDING BAR, CHROMED (LOWER FRAME) MEDICHOICE BARI WC 30W DSK ELR SEAT UPH,BLK NYLN 30X18-PMT XD WHL LOCK EXTENSION - PMT XD W/C PARAMOUNT XD 26W DSK ELR MEDICHOICE BARI WC 30W DSK SWF REAR WHL, 24" - PMT XD SEAT UPH,BLK NYLN 26X18-PMT XD W/C PARAMOUNT XD 26W DSK SWF FOOTREST, COMPLETE - PMT XD ELR BLACK PANEL - PMT XD MEDICHOICE BARI WC 26W DSK ELR POSITIONING BELT - PMT XD W/C PARAMOUNT XD 30W DSK SWF W/C PARAMOUNT XD 30W DSK ELR RPL KNOBS PLASTIC-PMT XD CSTR OVERBED TBLE GF8905-1A OVERBED TABLE TLT-TOP DLX REPLACEMENT FABRIC XFER CHAIR MOUNTING PLATE ASSEMBLY FT STOOL ECN BLK EPXY FIN 2/CS TOILET SAFETY RAILS VERSAFRAME REPL LOCKING CASTERS-MC000480 STOOL SAFETY STEP W/LONG HNDL VERSAFRAME TOILET SAFETY 5ESC20 ECONOMY SHWR CHR FTRST BATH MAT SURE-SAFE WHITE REPLACEMENT TIP HAMPER FOLDING ADJUSTABLE SHOWER CHAIR ALUM 5 CASTERS REPL CASTERS 7910A-1, 7915A-1 REPL NON-LOCK CASTERS-MC000480 SPREADER BAR 12" REPL SEAT SHOWER TRANSP CHAIR REPLACEMENT SEAT FOR MC000480 SHOWER CHAIR ALUM W/FT RST 5ESC20 ECONOMY SHOWER CHAIR TRANS BENCH HVY DUTY TRANS BENCH HVY DUTY 1EA EXTEN LEGS 4" FOR 7927/7929 SUCTION CUPS LEGS CANVAS 1-PIECE SLING CSTRS FOR IV POLEGF7012-1 CANE OFFSET BLACK SOFT GRP CANE OFFSET SILVER SOFT GRP

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device