BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    HAGER & WERKEN GMBH

    Reg #: 3003487388 · FEI: 3003487388 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    20
    Establishment Types
    5
    Classifications
    17

    Registration Details

    Registration Name
    HAGER & WERKEN GMBH
    Registration Number
    3003487388
    FEI Number
    3003487388
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ACKERSTRASSE 1
    City
    DUISBURG,DE-NOTA Hamburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K050658

    Owner / Operator

    Firm Name
    HAGER & WERKEN GMBH
    Operator Number
    9050764
    Address
    ACKERSTRASSE 1, --
    City
    DUISBURG
    State
    DE-NOTA
    Postal Code
    D-47269
    Country
    DE
    Correspondent
    Patrick - Rouillard

    US Agent

    Business Name
    HAGER WORLDWIDE, INC.
    Contact Name
    Patrick Rouillard
    Address
    441 19th St SE
    City
    Hickory
    State
    NC
    ZIP
    28602
    Country
    US
    Email
    [email protected]
    Phone
    828 6243300 ext. 3310

    Products

    Device Name Product Code
    Cement, Dental EMA
    Toothbrush, Manual EFW
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Eraser, Dental Stain MAU
    Instrument, Filling, Plastic, Dental EIY
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Floss, Dental JES
    Cotton, Roll EFN
    Pick, Massaging JET
    Tray, Fluoride, Disposable KMT
    Frame, Rubber Dam EJE
    File, Pulp Canal, Endodontic EKS
    Bur, Dental EJL
    Pin, Retentive And Splinting, And Accessory Instruments EBL
    Dental Hygiene Kit NXZ
    Accessories, Retractor, Dental EIF
    Teeth, Artificial, Posterior With Metal Insert ELJ

    Proprietary Names

    RESO PAC Happy Morning Toothbrush COMPO BLITZ MIRAWHITE PRO MIRA COMPO , COMPO BRUSH MIRAJECT ENDO RINSE MIRAFLOSS COTTON CLIPS II ROTOPROX PIC-BRUSH RFECT PLAST KIT Rubber Dam PREPOMETER SMOCLEAN PERFECT SPLINT TONG CLIN GEL TONG CLIN SET TONG GEL Spandex, cheek retractor, Mirahold cheek retractor OCCLU PRINT

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device