BEUDAMED
    FDA Registration Active 🇨🇳 China

    HENAN HUIBO MEDICAL CO., LTD

    Reg #: 3012852163 · FEI: 3012852163 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    33
    Establishment Types
    2
    Classifications
    17

    Registration Details

    Registration Name
    HENAN HUIBO MEDICAL CO., LTD
    Registration Number
    3012852163
    FEI Number
    3012852163
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Weishi Road Central, Nanyang New Energy, Economic & Technological Devlopment Zone
    City
    Nanyang City Henan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K202842

    Owner / Operator

    Firm Name
    Henan Huibo Medical CO., LTD
    Operator Number
    10053214
    Address
    Weishi Road Central, Nanyang New Energy, Economic & Technological Devlopment Zone
    City
    Nanyang City
    State
    Henan
    Postal Code
    473000
    Country
    CN
    Correspondent
    Boyle Wang

    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
    Elastomer, Silicone, For Scar Management MDA
    Mask, Surgical FXX
    Orthosis, Lumbar IQE
    Silicone Hydrogel For Scar Management PFP
    Joint, Ankle, External Brace ITW
    Non-Surgical Gown OEA
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Dressing, Compression MHW
    Respirator, Surgical MSH
    Beads, Hydrophilic, For Wound Exudate Absorption KOZ
    Mask, Scavenging KHA
    Dressing, Wound, Hydrophilic NAC
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Expander, Surgical, Skin Graft FZW
    Disinfectant, Medical Devices LRJ
    Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
    Pack, Hot Or Cold, Disposable IMD

    Proprietary Names

    medical silicone sheet dressings Tetyana Natural Silicone Scar Sheets-1.5"*2.8", 7 Reusable Sheets Puriderma Medical Silicone Scar Removal Sheets-1.6in*3 in,5 Reusable Sheets;5.9in*1.6 in,4 Reusable Sheets Aroamas Silicone Scar Removal Sheets-3in*1.6 in,8 Reusable Sheets,3in*1.6 in, 4 Reusable Sheets, 5.9in*1.6 in,4 Reusable St. Mege Silicone Scar Sheets-5.9''*1.6'',4 Reusable Sheets Skintensive ScarSmart Scar Sheets 3.5 in*1.6 in Zissa SILICONE SCAR SHEETS- starter kit-5 Sheets: 6.3" x 1.5", replenishment kit-3 Sheets: 6.3" x 1.5" Disposable surgical mask, surgical mask Mask, Face Mask, Nonwoven Face Mask, Medical Disposable face Mask Disposable medical surgical mask waist support, back support medical silicone gel dressings LUXROS Scar Gel -25g TEREZ & HONOR Advanced Silicone Scar Gel-30g Aroamas Advanced Medical Silicone Scar Gel-30g,45g AZALLY Medical Silicone Scar Gel-30g Teeth Whitening Gel Skintensive ScarSmart Scar Gel-45g Compression Garments Disposable Nonwoven Isolation Gown; Disposable Nonwoven Protective Clothing KN95 Protective Mask, Daily Respiratory Protective Mask Mask, Face Mask, Nonwoven Face Mask, Medical Disposable Face Mask Compression Bandage Respirator, Surgical, Health Care Particulate Respirator and Surgical Mask N95 Daily Respiratory Protective Mask N95 Respirator Foam dressing hydrocolloid dressings Alginate dressings medical skin stretching and secure wound closure system Alchocol Wipes; Disinfecting Hand Gel; Hand Sanitizer; Hand Sanitizer Gel; Hand Sanitizing Wipes; Sanitizing Wipes medical compression stockings Medical Discoloration Cooling Gel Patch Medical surgical mask

    Establishment Types

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