BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SIMEX MEDIZINTECHNIK GMBH

    Reg #: 3005813597 · FEI: 3005813597 · Expires 2026
    View on FDA
    Products
    46
    Proprietary Names
    50
    Establishment Types
    3
    Classifications
    46

    Registration Details

    Registration Name
    SIMEX MEDIZINTECHNIK GMBH
    Registration Number
    3005813597
    FEI Number
    3005813597
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Brueckstr. 30/1
    City
    Deisslingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K113291

    Owner / Operator

    Firm Name
    SIMEX MEDIZINTECHNIK GMBH
    Operator Number
    9086230
    Address
    Brueckstr. 30/1, --
    City
    DEISSLINGEN
    State
    DE-NOTA
    Postal Code
    78652
    Country
    DE

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Dilator, Tracheal KCG
    Depressor, Tongue, Non-Surgical FMA
    Hammer, Surgical FZY
    Laryngoscope, Rigid CCW
    Forceps, General & Plastic Surgery GEN
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Clamp HXD
    Needle, Suturing, Reusable GDL
    Bit, Drill HTW
    Speculum, Vaginal, Metal HDF
    Retractor, All Types EIG
    Tube, Tonsil Suction KCB
    Gouge, Surgical, General & Plastic Surgery GDH
    Dilator, Catheter GCC
    Mallet HXL
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Hemostat HRQ
    Forceps, Rongeur, Surgical EMH
    Cutter, Wire HXZ
    Scissors, Ophthalmic HNF
    Guide, Needle, Surgical GDF
    Scissors, General, Surgical LRW
    Handle, Scalpel GDZ
    Elevator HTE
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Scaler, Periodontic EMN
    Dilator, Cervical, Fixed Size HDQ
    Mirror, Mouth EAX
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Instrument, Cast Application/Removal, Manual LGG
    Chisel, Surgical, Manual FZO
    Spatula, Surgical, General & Plastic Surgery GAF
    Hook, Surgical, General & Plastic Surgery GDG
    Gag, Mouth KBN
    Chisel (Osteotome) KDG
    Saw HSO
    Retractor GAD
    Probe, Lachrymal HNL
    Curette, Periodontic EMS
    Punch, Surgical LRY
    Elevator, Surgical, Dental EMJ
    Tray, Surgical, Instrument FSM
    Hook, Tracheal KCH
    Tray, Impression, Preformed EHY
    Sound, Uterine HHM
    Cutter, Surgical FZT

    Proprietary Names

    Dilator, Tracheal Depressor, Tongue, Non-Surgical Hammer, Surgical Laryngoscope, Rigid Forceps, General & Plastic Surgery SIMEX200 SIMEX300 Clamp Needle, Suturing, Reusable Bit, Drill Speculum, Vaginal, Metal Retractor, All Types Tube, Tonsil Suction Gouge, Surgical, General & Plastic Surgery Dilator, Catheter Mallet Syringe, Periodontic, Endodontic, Irrigating Hemostat Forceps, Rongeur, Surgical Cutter, Wire Scissors, Ophthalmic Guide, Needle, Surgical Scissors, General, Surgical Handle, Scalpel Elevator Instrument, Manual, General Obstetric-Gynecologic Scaler, Periodontic Dilator, Cervical, Fixed Size Mirror, Mouth cuff M cuff S Instrument, Cast Application/Removal, Manual Chisel, Surgical, Manual Spatula, Surgical, General & Plastic Surgery Hook, Surgical, General & Plastic Surgery Gag, Mouth Chisel (Osteotome) Saw Retractor Probe, Lachrymal Curette, Periodontic Punch, Surgical Elevator, Surgical, Dental FloSure Ventilation Patch FloSure Tray, Surgical, Instrument Hook, Tracheal Tray, Impression, Preformed Sound, Uterine Cutter, Surgical

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility