BEUDAMED
    FDA Registration Active 🇨🇳 China

    PREMIUM PLUS (DONGGUAN) LIMITED

    Reg #: 3027234828 · FEI: 3027234828 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    66
    Establishment Types
    2
    Classifications
    34

    Registration Details

    Registration Name
    PREMIUM PLUS (DONGGUAN) LIMITED
    Registration Number
    3027234828
    FEI Number
    3027234828
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Flat 101, No.122, Tianqiao Road, Changping
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K251869

    Owner / Operator

    Firm Name
    Premium Plus (Dongguan) Limited
    Operator Number
    10092177
    Address
    Flat 101, No.122, Tianqiao Road, Changping
    City
    Dongguan
    State
    Guangdong
    Postal Code
    523581
    Country
    CN
    Correspondent
    Jessica Mao

    Products

    Device Name Product Code
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Scraper, Tongue LCN
    Chair, Dental, Without Operative Unit NRU
    Tape, Measuring, Rulers And Calipers FTY
    Needle, Dental DZM
    Dental Barriers And Sleeves PEM
    Activator, Ultraviolet, For Polymerization EBZ
    Accessory, Surgical Apparel LYU
    Holder, Film, X-Ray EGZ
    Gauze / Sponge,Nonresorbable For External Use NAB
    Applicator, Resin KXR
    Toothbrush, Manual EFW
    Syringe, Restorative And Impression Material EID
    Mouthpiece, Saliva Ejector DYN
    Cup, Prophylaxis EHK
    Evacuator, Oral Cavity EHZ
    Unit, Syringe, Air And/Or Water ECB
    Handle, Instrument, Dental EJB
    Instruments, Dental Hand DZN
    Unit, Operative Dental, Accessories NRD
    Cannula, Surgical, General & Plastic Surgery GEA
    Indicator, Physical/Chemical Sterilization Process JOJ
    Wrap, Sterilization FRG
    Frame, Rubber Dam EJE
    Tray, Impression, Preformed EHY
    Absorber, Saliva, Paper KHR
    Retractor, All Types EIG
    Tray, Fluoride, Disposable KMT
    Tray, Surgical, Instrument FSM
    Mixer, Cement, For Clinical Use JDZ
    Instrument, Manual, Surgical, General Use MDM
    Mirror, Mouth EAX
    Brush, Scrub, Operating-Room GEC

    Proprietary Names

    Eye shield Light shield Disposable Prophy Angles Tongue cleaners Headrest Covers Endo Rulers Endo Measuring Blocks Flowable composite and etching gel tips Applicator tips X-Ray Sensor Sleeves/ Mouth Mirror Sleeves Tubing Sleeves Chair Sleeves Flowable Composite Syringe Sleeves Impression Gun Sleeves Curing Light Sleeves, Light Guide Sleeves HVE Tube Sleeves Intraoral Camera Sleeves Handpiece Sleeves Barrier sleevese, barrier envelopes Headrest Sleeves Bite Block Sleeves Syringe/HVE Sleeves Light Handle Sleeves Keyboard Sleeves/ X-Ray Head Sleeves, PC mouse sleeves Instrument Tray Sleeves, instrument sleeves Activator, for polymerization, Dental Curing Light Face masks X-Ray Bite Cushions, Bite Wing Loops Disposable peel-n-stick sensor holders X-Ray film holder, film clips Endo sponges/cushions Micro Applicators Brush applicator, brush tips, applicators interdental brush, brush Intraoral Syringe Tips Impression syringes,curved tip syringe Saliva ejectors Disposable Prophy Cups Disposable Prophy Brushes Oral evacuators HVE Suction Tubes air-water syringe tips greenline syringe tips Hand instruments Plastic wedges Composite syringe gun, composite syringe tips organisers, dispensers, holders, retainers, denture boxes tooth fracture detector,spatula, napkin holders, instrument rings, mask extenders Dental accessories Surgical aspirator tips Sterilization pouches Rubber dam frame Impression trays, 3-IN-1 Trays Dental bibs Tray papers Cheek retractor, mouth props, intraoral lippers Fluoride trays Plastic trays, Tray racks, Instrument mats, Cabinet tray Sterilisation Cassettes Dynamic Mixing Tips Mixing cup, Mixing well, Mixing bowl, Dappen dish, Mixing ring Bur tray, Bur dispenser, Bur Block, Bur Stand, Endo Holder, Endo Organizer Box Dental instrument holder Endo dispenser Mouth mirrors, Intraoral Mirrors Bur brush, brass/stainess steel wire brushes, aspirator brush

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device