BEUDAMED
    FDA Registration Active 🇨🇳 China

    Wellmed Dental Medical Supply Co., Ltd

    Reg #: 3010598169 · FEI: 3010598169 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    34
    Establishment Types
    2
    Classifications
    37

    Registration Details

    Registration Name
    Wellmed Dental Medical Supply Co., Ltd
    Registration Number
    3010598169
    FEI Number
    3010598169
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    301 Zhongxing Science and Technology Building, No.64, Xin'an 2nd Road, Baoan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K222697

    Owner / Operator

    Firm Name
    Wellmed Dental Medical Supply Co., Ltd.
    Operator Number
    10047916
    Address
    301 Zhongxing Science and Technology Building, No.64, Xin'an 2nd Road, Baoan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    CN-44
    Country
    CN
    Correspondent
    RENXIAN TANG

    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
    Accessory, Surgical Apparel LYU
    Unit, Operative Dental, Accessories NRD
    Mask, Scavenging KHA
    Point, Paper, Endodontic EKN
    Dispenser, Solid Medication NXB
    Gauze / Sponge,Nonresorbable For External Use NAB
    Wax, Dental, Intraoral EGD
    Gown, Examination FME
    Cover, Shoe, Operating-Room FXP
    Gutta-Percha EKM
    Needle, Dental DZM
    Non-Surgical Gown OEA
    Apron, Leaded EAJ
    Mask, Surgical FXX
    Cup, Prophylaxis EHK
    Evacuator, Oral Cavity EHZ
    Tray, Surgical LRP
    Aligner, Bracket, Orthodontic ECQ
    Instrument, Surgical, Disposable KDC
    Mouthpiece, Saliva Ejector DYN
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Applicator, Resin KXR
    Instruments, Dental Hand DZN
    Floss, Dental JES
    Unit, Syringe, Air And/Or Water ECB
    Dental Barriers And Sleeves PEM
    Drape, Surgical, Exempt PUI
    Bedding, Disposable, Medical KME
    Cap, Surgical FYF
    Toothbrush, Manual EFW
    Wrap, Sterilization FRG
    Indicator, Physical/Chemical Sterilization Process JOJ
    Fiber, Medical, Absorbent FRL
    Tray, Impression, Preformed EHY
    Mirror, Mouth EAX
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY

    Proprietary Names

    ACCESSORY, SURGICAL APPAREL UNIT, OPERATIVE DENTAL, ACCESSORIES Disposable Mask POINT, PAPER, ENDODONTIC Dispenser, solid medication Gauze/sponge,nonresorbable for external use WAX, DENTAL, INTRAORAL GOWN, EXAMINATION COVER, SHOE, OPERATING-ROOM GUTTA-PERCHA Disposable Dental Needles Apron, leaded Disposable Medical Face Mask (DF3-001) CUP, PROPHYLAXIS EVACUATOR, ORAL CAVITY TRAY, SURGICAL ALIGNER, BRACKET, ORTHODONTIC INSTRUMENT, SURGICAL, DISPOSABLE MOUTHPIECE, SALIVA EJECTOR APPLICATOR, ABSORBENT TIPPED, NON-STERILE Applicator Resin INSTRUMENTS, DENTAL HAND FLOSS, DENTAL UNIT, SYRINGE, AIR AND/OR WATER Dental Barrier and Sleeves BEDDING, DISPOSABLE, MEDICAL CAP, SURGICAL Toothbrush Self Sealing Sterilization Pouches FIBER, MEDICAL, ABSORBENT TRAY, IMPRESSION, PREFORMED MIRROR, MOUTH Face Mask Face Shield

    Establishment Types

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