BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Solventum Poland Manufacturing SP. ZO.O

    Reg #: 3032763783 · FEI: 3032763783 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    7

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    Registration Details

    Registration Name
    Solventum Poland Manufacturing SP. ZO.O
    Registration Number
    3032763783
    FEI Number
    3032763783
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Site Wroclaw Ul. Kwidzynska 6
    City
    Wroclaw Dolnoslaskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K140657

    Owner / Operator

    Firm Name
    Solventum US LLC
    Operator Number
    10091183
    Address
    12930 IH 10 West
    City
    San Antonio
    State
    TX
    Postal Code
    78249
    Country
    US
    Correspondent
    JEFFERY J SCHORR

    US Agent

    Business Name
    SOLVENTUM US LLC
    Contact Name
    JEFFERY SCHORR
    Address
    12930 IH 10 West
    City
    San Antonio
    State
    TX
    ZIP
    78249
    Country
    US
    Email
    [email protected]
    Phone
    210 2556721

    Products

    Device Name Product Code
    Bandage, Cast ITG
    Cap, Device Disinfectant QBP
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Tape And Bandage, Adhesive KGX
    Bracket, Metal, Orthodontic EJF
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Bracket, Ceramic, Orthodontic NJM

    Proprietary Names

    OPTICLUDE ORTHOPTIC EYE PATCH OPTICLUDE 3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch 3M(TM) Nexcare(TM) Gentle Removal Eye Patch

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)