BEUDAMED
    FDA Registration Active 🇨🇳 China

    Zhejiang Gongdong Medical Technology Co., Ltd

    Reg #: 3005739529 · FEI: 3005739529 · Expires 2026
    View on FDA
    Products
    40
    Proprietary Names
    78
    Establishment Types
    3
    Classifications
    40

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    Registration Details

    Registration Name
    Zhejiang Gongdong Medical Technology Co., Ltd
    Registration Number
    3005739529
    FEI Number
    3005739529
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    a)No 10 & 39 ,Beiyuan Ave., b)No.88 Jingxian Rd. Huangyan
    City
    TAIZHOU Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K082042

    Owner / Operator

    Firm Name
    ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
    Operator Number
    9072045
    Address
    BEICHENG INDUSTRIAL AREA, HUANGYAN
    City
    TAIZHOU
    State
    Zhejiang
    Postal Code
    318020
    Country
    CN
    Correspondent
    Jingxiang - Zhang

    Products

    Device Name Product Code
    Micro Pipette JRC
    Tube, Collection, Capillary Blood GIO
    Cuvette, Thermostated JRI
    Speculum, Ent EPY
    Speculum, Rectal FFQ
    Depressor, Tongue, Non-Surgical FMA
    Retractor, Vaginal HDL
    Trap, Sterile Specimen BYZ
    Tourniquet, Nonpneumatic GAX
    Bottle, Roller, Tissue Culture KJC
    Basin, Emesis FNY
    Otoscope ERA
    Container, Sharps MMK
    Culture Media, Non-Selective And Non-Differential JSG
    Urine Collection Kit (Excludes Hiv Testing) OIE
    Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD
    Curette, Ear JYG
    Accessory, Surgical Apparel LYU
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Speculum, Vaginal, Nonmetal HIB
    Applicator, Absorbent Tipped, Sterile KXG
    Tray, Surgical, Instrument FSM
    Container, Specimen, Sterile FMH
    Forceps HTD
    System, Automated Platelet Aggregation JOZ
    Dispenser, Liquid Medication KYX
    Pad, Alcohol, Device Disinfectant LKB
    Light, Surgical, Accessories FTA
    Container, Specimen, Non-Sterile NNI
    Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile NNL
    Dish, Tissue Culture KIZ
    Instrument, Manual, Surgical, General Use MDM
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Pack, Hot Or Cold, Disposable IMD
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Cassettes, Tissue IDZ
    Bottle, Collection, Vacuum KDQ
    Device, Specimen Collection LIO
    Culture Media, Non-Propagating Transport JSM
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG

    Proprietary Names

    GONGDONG TRANSFER PIPETTE Capilary blood collection tube with clot activator and Gel;Capilary blood collection tube with EDTAK2; Capilary Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.8% Capilary blood collection tube with EDTAK3;Capilary blood collection tube with Lithium heparin; Capilary blood collection tube with clot activator;Capilary blood collection tube no activator; Capilary Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.2%; Capilary blood collection tube with Sodium heparin;Capilary blood collection tube with sodium fluoride/sodium heparin; Capilary blood collection tube with sodium fluoride/potassium oxalate GONGDONG CUVETTE Disposable Otoscope Specula Cover, 2.5mm, Pediatric Disposable Otoscope Specula Cover, 4.25mm, Adult Tongue Depressor DISPENSER, LIQUID MEDICATION Latex-Free Tourniquet, Surgical tape Placenta basin Sharp Container,Needle collector Viral Transport Media Kit Urine Clean Catch Collection Set & Tube Sterile Blood Culture Diversion Tube, No Activator GDC-03-F, GDC-03-X, GDC-05-F, GDC-05-X, GDC-07-F, GDC-07-X, GDC-13-X,SC-01Q, SC-02Q, SC-05Q, SC-01G, SC-02G, SC-06 MULTIPLE &ACCESSORIES Disposable Face shield PPLICATOR, ABSORBENT TIPPED non-sterile, sampling swab kit Non-Sterile GONGDONG DISPOSABL VAGINAL SPECULUM Absorbent tipped applicator; Sampling Swab APPLICATOR, ABSORBENT TIPPED sterile, sampling swab kit Sterile, Saliva Collection Kit Vacuum specimen collection tube NO ADDIT; Plastic Conical Bottom Tube with Preservative for Urinalysis; Plastic Round Bottom Tube with Preservative for Urinalysis; FLUID COLLECTION BAG Transport tube Cryogenic Vial Sterile Urine Specimen Containers w/ needle cap Sterile Urine Specimen Containers with Temperature Strip; Sterile Urine Specimen Containers; Sample collection tubes Vacuum Urine Tube urine container Midstream catch kit Urine Collection Kit (Excludes HIV testing) Disposable Vaginal Speculum BAPA Tube for T-TAS 01 Dispenser, Liquid Medication - Feeding Syringes, Dispensers 20ml Dosage cup Gongdong ALCOHOL PAD Lighted Handle Cover Test tube Gongdong Centrifugation Tube Sample Cup& Specimen container Vacumm Urine tube Saliva Collection Kit,NON Sterile Biohazard Bags Quantisal Expressor (filter frit) with lid and ring Urine Transfer Straw Urine Specimen Collection Kit Specimen Bag Quantisal Expressor (filter frit) without lid Synergy Beaker; Gongdong Vial Collection Containers; Gongdong Vial DOA Kits; Gongdong Vial Transport Containers; Gongdong Petri dish Plastic Culture Dishes INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Light handle cover SHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) Instant hot pack CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE Biopsy foam pads;embedding rings;storage drawer;tissue capsules Semi Rigid Suction Canister System Disposable Urine Collection Tube, 4ml,7ml,8ml,10ml round or conical bottom with Boric acid Additve SPECIMEN COLLECTION HOLDER EQUIPMENT, LABORATORY, A SPECIFIC MEDICAL USE GENERAL PURPOSE, LABELED OR PROMOTED FOR Holder & Safety Holder Universal Tips ,Pipette tip with filter 10ul,20ul,100ul,200ul,1000ul,1250ul Inoculation Loop and Needles Culture Plate gongdong petri dish

    Establishment Types

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