BEUDAMED
    FDA Registration Active 🇨🇳 China

    ZOGEAR Medical Co., Ltd.

    Reg #: 3010583458 · FEI: 3010583458 · Expires 2026
    View on FDA
    Products
    75
    Proprietary Names
    79
    Establishment Types
    2
    Classifications
    75

    Registration Details

    Registration Name
    ZOGEAR Medical Co., Ltd.
    Registration Number
    3010583458
    FEI Number
    3010583458
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.166, Industrial Concentration Area, Dayi Town
    City
    Yizheng Jiangsu
    Country
    CN

    Owner / Operator

    Firm Name
    ZOGEAR Medical Co., Ltd.
    Operator Number
    10045283
    Address
    No.166, Industrial Concentration Area, Dayi Town
    City
    Yizheng
    State
    Jiangsu
    Postal Code
    211409
    Country
    CN
    Correspondent
    Yongmei Yan

    US Agent

    Business Name
    Humiss Inc.
    Contact Name
    James St. WU
    Address
    1500 N Grant St Ste R
    City
    Denver
    State
    CO
    ZIP
    80203
    Country
    US
    Email
    [email protected]
    Phone
    720 7595888

    Products

    Device Name Product Code
    Handle, Instrument, Dental EJB
    Instrument, Contouring, Matrix, Operative EKF
    Tube Mount, X-Ray, Diagnostic IYB
    Gauze / Sponge,Nonresorbable For External Use NAB
    Hydrazone Colorimetry, Alt/Sgpt CKD
    Tray, Fluoride, Disposable KMT
    Accessory, Surgical Apparel LYU
    Cleanser, Denture, Over The Counter EFT
    Pill Crusher/Cutter OHY
    Dress, Surgical FYE
    Connector, Catheter GCD
    Cleanser, Denture, Prescription NUX
    Instrument, Hand, Calculus Removal ELA
    Instruments, Dental Hand DZN
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Scraper, Tongue LCN
    Paper, Articulation EFH
    Unit, Oral Irrigation EFS
    Chair, Dental, Without Operative Unit NRU
    Band, Preformed, Orthodontic ECM
    Band, Elastic, Orthodontic ECI
    Zinc Oxide Eugenol EMB
    Device, Digital Image Storage, Radiological LMB
    Instrument, Manual, Surgical, General Use MDM
    Container, Specimen, Non-Sterile NNI
    Mouthpiece, Saliva Ejector DYN
    Utensil, Eating ILC
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Container, Liquid Medication, Graduated KYW
    Forceps, Articulation Paper EFK
    Floss, Dental JES
    Mask, Scavenging KHA
    File, Pulp Canal, Endodontic EKS
    Shoe And Shoe Cover, Conductive BWP
    Mirror, Mouth EAX
    Film, Radiographic IWZ
    Non-Surgical Gown OEA
    Wax, Dental, Intraoral EGD
    Instrument, Filling, Plastic, Dental EIY
    Post, Root Canal ELR
    Point, Paper, Endodontic EKN
    Applicator, Vaginal HGD
    Cap, Surgical FYF
    Shield, Protective, Personnel KPY
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Tray, Surgical LRP
    Toothbrush, Manual EFW
    Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter NKJ
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Instrument, Ligature Tucking, Orthodontic ECP
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Catheter, Continuous Irrigation GBQ
    Cotton, Roll EFN
    Respirator, Surgical MSH
    Absorber, Saliva, Paper KHR
    Blade, Scalpel GES
    Needle, Dental DZM
    Probe, Periodontic EIX
    Unit, Syringe, Air And/Or Water ECB
    Handle, Scalpel GDZ
    Cup, Prophylaxis EHK
    Accessories, Retractor, Dental EIF
    Carrier, Amalgam, Operative EKI
    Holder, Film, X-Ray EGZ
    Frame, Rubber Dam EJE
    Teeth, Artificial, Posterior With Metal Insert ELJ
    Kit, Surgical Instrument, Disposable KDD
    Cover, Cast KIA
    Tray, Impression, Preformed EHY
    Material, Impression Tray, Resin EBH
    Wheel, Polishing Agent EJQ
    Plugger, Root Canal, Endodontic EKR
    Unit, Suction Operatory EBR
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Syringe, Restorative And Impression Material EID

    Proprietary Names

    HANDLE, INSTRUMENT, DENTAL INSTRUMENT, CONTOURING, MATRIX, OPERATIVE Tube mount, x-ray, diagnostic Gauze/sponge,nonresorbable for external use HYDRAZONE COLORIMETRY, ALT/SGPT Dental Disposable Fluoride Tray ACCESSORY, SURGICAL APPAREL gloves Cleaning Tablet Pill crusher/cutter DRESS, SURGICAL CONNECTOR, CATHETER Cleanser, denture, prescription INSTRUMENT, HAND, CALCULUS REMOVAL INSTRUMENTS, DENTAL HAND Ovulation test strip Tongue scraper PAPER, ARTICULATION Electric Dental Water Flosser CHAIR, DENTAL, WITHOUT OPERATIVE UNIT BAND, PREFORMED, ORTHODONTIC BAND, ELASTIC, ORTHODONTIC ZINC OXIDE EUGENOL Device, digital image storage, radiological INSTRUMENT, MANUAL, SURGICAL, GENERAL USE CONTAINER, SPECIMEN, NON-STERILE Mouthpiece, saliva ejector UTENSIL, EATING SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC CONTAINER, LIQUID MEDICATION, GRADUATED FORCEPS, ARTICULATION PAPER FLOSS, DENTAL MASK, SCAVENGING FILE, PULP CANAL, ENDODONTIC SHOE AND SHOE COVER, CONDUCTIVE MIRROR, MOUTH Film, radiographic protective coverall, isolation coverall WAX, DENTAL, INTRAORAL INSTRUMENT, FILLING, PLASTIC, DENTAL POST, ROOT CANAL POINT, PAPER, ENDODONTIC VAGINAL APPLICATOR CAP, SURGICAL Shield, protective, personnel EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE TRAY, SURGICAL TOOTHBRUSH, MANUAL CUSHION, PAD, DENTURE, WAX IMPREGNATED COTTON, OVER THE COUNTER Shield, eye, ophthalmic,face shield,eyewear,face&eye protector INSTRUMENT, LIGATURE TUCKING, ORTHODONTIC CanalPro color syringes SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING Catheter COTTON, ROLL Surgical Masks Disposable Medical Masks Dental Bib BLADE, SCALPEL NEEDLE, DENTAL CanlPro Tips PROBE, PERIODONTIC UNIT, SYRINGE, AIR AND/OR WATER HANDLE, SCALPEL CUP, PROPHYLAXIS ACCESSORIES, RETRACTOR, DENTAL CARRIER, AMALGAM, OPERATIVE Holder, film, x-ray FRAME, RUBBER DAM TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT Dental care kit COVER, CAST TRAY, IMPRESSION, PREFORMED MATERIAL, IMPRESSION TRAY, RESIN POLISHING AGENT PLUGGER, ROOT CANAL, ENDODONTIC UNIT, SUCTION OPERATORY APPLICATOR, ABSORBENT TIPPED, NON-STERILE SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)