BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    S & Mohr America, S.A. DE C.V.

    Reg #: 3020777588 · FEI: 3020777588 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    58
    Establishment Types
    2
    Classifications
    18

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    Registration Details

    Registration Name
    S & Mohr America, S.A. DE C.V.
    Registration Number
    3020777588
    FEI Number
    3020777588
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CIRCUITO DE LA INDUSTRIA PONIENTE LOTE 10 C, PARQUE IND. EL CERRILLO
    City
    ESTADO DE MEXICO Ciudad de Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K141389

    Owner / Operator

    Firm Name
    Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.
    Operator Number
    9099982
    Address
    Ibni Melek Mah., Organize Sanayi Bolgesi
    City
    Tire
    State
    Izmir
    Postal Code
    35900
    Country
    TR

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Drain, Tee (Water Trap) BYH
    Support, Breathing Tube JAY
    Mouthpiece, Breathing BYP
    Set, Administration, Intravascular FPA
    Pump, Infusion FRN
    Humidifier Nebulizer Kit OGG
    Filter, Bacterial, Breathing-Circuit CAH
    Connector, Airway (Extension) BZA
    Mask, Oxygen BYG
    Mask, Oxygen, Low Concentration, Venturi BYF
    Mask, Oxygen, Non-Rebreathing KGB
    Bag, Reservoir BTC
    Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
    Valve, Non-Rebreathing CBP

    Proprietary Names

    Altech Meditera 009118 Disposable 22mm Single Limb (1.8m) 009119 Disposable 15mm Single Limb (1.8m) 005519- 15mm Dual Limb Breathing Circuit 005520- 22mm Dual Limb Breathing Circuit 005060 22 MM BREATHING CIRCUIT / LEAK PORT Standard Breathing Circuit with Face Mask - Child/Adult Small Standard Breathing Circuit with Face Mask - Toddler Standard Breathing Circuit with Mouthpiece Standard Breathing Circuit with Face Mask - Adult Medium Standard Breathing Circuit with Face Mask - Adult Large BC21092- Standard Breathing Circuit with Mouthpiece BC21273- Standard Breathing Circuit with Face Mask- Adult Large BC21087- Standard Breathing Circuit with Face Mask - Toddler BC21086 – Standard Breathing Circuit with Face Mask- Infant BC21089- Standard Breathing Circuit with Face Mask – Adult Medium BC21088- Standard Breathing Circuit with Face Mask – Child/ Adult Small TRACHEOSTOMY FILTER WITH HME PAPER BC21090- Standard Breathing Circuit with Trach BC21281 – Breathing Circuit Custom Trach SAPPHIRE INFUSION PUMP Bubble Kit Bubble CPAP Seattle PAP Plus BHF 104 Administration (IV) Set ErgoStar AMT5M Size 5 Anesthesia Mask AMT4M Size 4 Anesthesia Mask AMT6M Size 6 Anesthesia Mask AMT3M Size 3 Anesthesia Mask HME712 - Heat Moisture Exchanger with Filter BACTERIA FILTER WITH SOFT CAP PP BACTERIA HME FILTER PP WITH SOFT CAP WITH FOAM BKM953H-B - Anesthesia Breathing Circuit Kit 31161 - HME with Flex Tubes BV001 - Bacterial Viral Filter BKM953H - Anesthesia Breathing Circuit Kit AL-08021.V001 BV002 - Bacterial Viral Filter BB1M Anesthesia Breathing Bag, Finish 1L US-Kits AL-1300-170/5.V002 AL-1100-170/5.V002 AL-1100.V002 AL-1400.V005 BGA7M 71” Anesthesia Breathing Circuit - Pediatric BGE7M 71” Anesthesia Breathing Circuit - Adult BGE9M 94” Anesthesia Breathing Circuit - Adult BGA9M 94” Anesthesia Breathing Circuit - Pediatric SAPPHIRE ADMINISTRATION SET 007616 IPBB BREATHING CIRCUIT (BREAS) 007387 22MM DISPOSABLE BREATHING CIRCUIT WITH EXHALATION VALVE 007857 15 MM DISP PT CIRCUIT W EX VAL TRAA003P AL-12300.V001 CATHETER MOUNT (ALTECH) Leak Port (single pack) VEN004 AB-3010-000/9.V001 EXHALATION VALVE KIT

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)