BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD

    Reg #: 3013496867 · FEI: 3013496867 · Expires 2026
    View on FDA
    Products
    65
    Proprietary Names
    78
    Establishment Types
    4
    Classifications
    65

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    Registration Details

    Registration Name
    SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
    Registration Number
    3013496867
    FEI Number
    3013496867
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    South Fanlou Road, Shan County Development Zone
    City
    Heze Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K203436

    Owner / Operator

    Firm Name
    Shandong Zhushi Pharmaceutical Group Co., Ltd
    Operator Number
    10052646
    Address
    South Fanlou Road, Shan County Development Zone
    City
    Heze
    State
    Shandong
    Postal Code
    274300
    Country
    CN
    Correspondent
    Kunfu Zhu

    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
    Thermometer Kit PXH
    Polymer Patient Examination Glove LZA
    Accessory, Surgical Apparel LYU
    Mask, Oxygen BYG
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI
    Mask, Scavenging KHA
    Suit, Surgical FXO
    Massager, Therapeutic, Manual LYG
    Mask, Surgical FXX
    Non-Surgical Gown OEA
    Bag, Reservoir BTC
    Absorber, Saliva, Paper KHR
    Vinyl Patient Examination Glove LYZ
    Continuous Measurement Thermometer FLL
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Cable, Electrode IKD
    Elastomer, Silicone, For Scar Management MDA
    Support, Breathing Tube JAY
    Enteral Administration Kit (Adult & Pediatric) PRM
    Unit, Syringe, Air And/Or Water ECB
    Tray, Impression, Preformed EHY
    Cup, Menstrual HHE
    Catheter, Drainage, Intraoral/Extraoral OAJ
    Irrigator, Sinus KAR
    Unit, Oral Irrigation EFS
    Shoe And Shoe Cover, Conductive BWP
    Applicator, Absorbent Tipped, Sterile KXG
    Cleanser, Denture, Over The Counter EFT
    Gauze / Sponge,Nonresorbable For External Use NAB
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Probe, Periodontic EIX
    Bandage, Cast ITG
    Dressing, Wound, Hydrophilic NAC
    Cannula, Nasal, Oxygen CAT
    Pack, Hot Or Cold, Disposable IMD
    Syringe, Irrigating (Non Dental) KYZ
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Dispenser, Liquid Medication KYX
    System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile NNZ
    Douche Apparatus, Vaginal, Therapeutic HED
    Airway, Oropharyngeal, Anesthesiology CAE
    Cotton, Roll EFN
    Retainer, Surgical GCZ
    Hemostat HRQ
    Eraser, Dental Stain MAU
    Insufflator, Vaginal HEC
    Gown, Surgical FYA
    Cap, Surgical FYF
    Needle, Dental DZM
    Micro Pipette JRC
    Pack, Hot Or Cold, Reusable IME
    Catheter, Ventricular, General & Plastic Surgery GBS
    Accessories, Retractor, Dental EIF
    Dam, Rubber EIE
    Compressor, Air, Portable BTI
    Mirror, Mouth EAX
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Forceps, Tooth Extractor, Surgical EMG
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Tape And Bandage, Adhesive KGX
    Pad, Eye HMP
    Mouthpiece, Saliva Ejector DYN
    Accessories, Implant, Dental, Endosseous NDP
    Applicator, Absorbent Tipped, Non-Sterile KXF

    Proprietary Names

    Theometer Disposable Nitrile Examination Gloves Disposable Medical Face Mask, Protective Suit, Medical Isolation Mask Disposable Oxygen Mask Disposable Sterile Syringe, Disposable Sterile Insulin Syringe, Disposable Sterile Injection Needles Face Mask Disposable Medical Face Mask Acupoint Therapy Patch / Detox Foot Patch / Foot Pad, Magnetic Therapy Patch Disposable Surgical Face Mask Isolation Gown Protective Suit Medical Oxygen Bag BIB/dental bib Disposable Vinyl Examination Gloves Infrared Thermometer Disposable Sputum Suction Bag ECG cable Silicone Scar Gel Silicone Scar Patch Single Patient Breathing Tube Breathing Tube, Endotracheal Tube Holder, Endotracheal Tube Support Clip, Breathing Tube Supports, Stomach Tube (Gastric Calibration Tube), Leving tube, Feeding tube, Enteral feeding bag UNIT, SYRINGE, AIR ANDIOR WATER Thermoplastic Mouth Tray, Mouth Piece/Dental mouthpiece,Teeth whitening tray; TRAY, IMPRESSION, PREFORMED Menstrual cup Disposable Body Surface Drainage Tube Portable Oral Imigator Rechangeable, SINUS IRRIGATOR, Nasal WashBottle Cordless Oral Irigator/Cordless DentalFlosser, Teether, Nozzle Tips for Water Flosser Oral irrigation unit/Dental Oral Irrigator, Water Flosser, DentalFlosser, Dental Water Jet, Medical Isolation Shoe Cover Single use sampler Mouthwash, Denture cleansing tablets, Cleanser, Denture, Denture Cleanser Disposable Medical Gauze / Sponge, Gauze Sponges, Non Woven Sponges, Non Woven Swabs, Abdominal Pads PROBE, PERIODONTIC, Mouth Mirror Fiberglass Casting Tape, Gypsum powder First-aid Bandage Disposable Nasal Oxygen Tube Heat pads Cooling Gel Patch, Heat pads, Cold Compress Gel Far-infrared Physiotherapy Patch/Magnetic heat Patch/Ironing Therapy Patch/Disposable Infusion Hot Compress Patch Heat Patch / Hyperthermia Patch/Gynecological Heat Patch/Steam Eye Mask Medical Ice Pad/Medical Ice Cap/Medical Antipyretic Patch/Medical Antipyretic Gel Sandwiched Moxibustion/Cauterize Hot Patch/Photoconductive Gel/Photon Cold Gel Disposable Sterile Irrigator medical polymer splint Syringe Luer lock tip Cap Drainage Bags Vaginal scrubber Disposable Medical Laryngeal Mask Absorbent Cotton Balls, Disinfection Cotton Ball, Swab and Piece, prophy angle, cotton roll/Dental cotton roll Retainer Box, Denture box Medical Tweezers Teeth Whitening Pen, Teeth Whitening Toothpaste, teeth whitening machine, Whitening Materials, Teeth Whitening Kit(Regular Strength Serum,Maximum Strength Serum,Desensitizing Serum,Teeth Whitening GEL> , Dione Cold Light Tooth WhiteningInstrument, Enamel Care/Colour Corrector/Hyaluronic Serum Vaginal Stuffing Adsorb Plug Disposable Surgical Gown Medical Cap Dental anesthesia needle Pipette Pain relief cream Pain relief patch Disposable Sterile Catheter Mouth Prop Dental Dam;Dental Gum Dam;Gum Protector Gel ;Gingival Protection Gel Medical compression atomizer Disposable Dental Instrument Kit 3-Layer Medical Face Masks (XMM3L3C) / Disposable Surgical Face Mask (ZS-B), 3-Layer Medical Face Masks with ties (XMM3HT)/Disposable Surgical Face Mask (ZS-S) Liquid Dressing, Medical Sodium Hyaluronate Skin Repair Solution, Medical Sodium Hyaluronate Gel for Skin Repair, Medical Sodium Hyaluronate Patch for Skin Repair, Wound nursing ointment, Medical skin repair liquid dressings Dental Probe Blood Collection Needle Self-Adhesive Bandage / Elastic Bandage / Medical Breathable Tape Hydrogel Under Eye Patch MOUTHPIECE, SALIVA EJECTOR Blunt tip dispensing needle, scanbody, analog Cotton Swabs

    Establishment Types

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