BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    The Surgical Company International B.V.

    Reg #: 3038241934 · FEI: 3038241934 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    72
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    The Surgical Company International B.V.
    Registration Number
    3038241934
    FEI Number
    3038241934
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Paalbergweg 3
    City
    Amsterdam Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K252636

    Owner / Operator

    Firm Name
    THE SURGICAL COMPANY INTERNATIONAL BV
    Operator Number
    9101201
    Address
    Paalbergweg 3, --
    City
    Amsterdam
    State
    Noord-Holland
    Postal Code
    1105 AG
    Country
    NL
    Correspondent
    Federica Federici

    US Agent

    Business Name
    TSC Life US, Inc.
    Contact Name
    Christopher Duffie
    Address
    6400 S Fiddlers Green Cir Ste 305
    City
    Greenwood Village
    State
    CO
    ZIP
    80111
    Country
    US
    Email
    [email protected]
    Phone
    773 5204980

    Products

    Device Name Product Code
    Warmer, Thermal, Infusion Fluid LGZ
    System, Thermal Regulating DWJ
    Stand, Infusion FOX

    Proprietary Names

    Fluido Compact Control Module Fluido Compact Warming Module Fluido Compact Standard Set Fluido Compact Standard Set with Drip Chamber Mistral-Air Half Upper Body Blanket (silver) Mistral-Air Tube (blue) Mistral-Air Full Underbody (silver) Mistral-Air Full Body Surgical Access - Sterile (white) Mistral-Air Upper Body Blanket (white) Mistral-Air Paediatric Blanket (white) Mistral-Air Paediatric Blanket (silver) Mistral-Air Torso Blanket (white) Mistral-Air Adult Blanket (silver) Mistral-Air Adult Blanket (white) Mistral-Air Lower Body Blanket (white) Mistral-Air Plus Warming Unit 110-120V~, 60Hz Mistral-Air Lower Body Blanket (silver) Mistral-Air Full Body Surgical Access - Non-sterile (white) Mistral-Air Upper Body Blanket (silver) Mistral-Air Underbody (silver) Mistral-Air Neonatal Blanket (silver) Mistral-Air Half Upper Body Blanket (white) 672100 Fluido Compact Standard Set with Drip Chamber 650200 Fluido Compact Warming Module 650100-US Fluido Compact Control Module 672000 Fluido Compact Standard Set Fluido® Blood & Fluid Warmer (115V) Fluido® Compressor Fluido® Standard Set Fluido® IV-Pole Fluido® Pressure Chambers Fluido® Trauma Set Fluido® AirGuard Mistral Air® Lower Surgical Access White (sterile) Mistral Air® (forced air warming unit 100-125 V~, 50/60 Hz) Mistral Air® Warming Suit S Mistral Air® Premium Full Underbody Mistral Air® Premium Warming Suit S Mistral Air® Faceshield Mistral Air® Torso Plus Mistral Air® Upper Body Plus Mistral Air® Paediatric Underbody Plus Mistral Air® Warming Suit L Mistral Air® Premium Half Upper Body Mistral Air® Premium Lower Body Mistral Air® Premium Adult Mistral Air® Premium Half Underbody Mistral Air® Warming Suit M Mistral Air® Half Underbody Plus Mistral Air® Premium Neonatal Mistral Air® Lithotomy Plus Mistral Air® Neonatal Plus Mistral Air® Paediatric Plus Mistral Air® Premium Warming Suit L Mistral Air® Warming Blanket Tube Mistral Air® Lower Surgical Access Plus (sterile) Mistral Air® Half Upper Body Plus Mistral Air® Premium Warming Suit XL Mistral Air® Cardiac Blanket (sterile) Mistral Air® Full Underbody Plus Mistral Air® Surgical Access Plus Mistral Air® Premium Paediatric Underbody Mistral Air® Lower Body Plus Mistral Air® Cardiac Blanket Plus (sterile) Mistral Air® Premium Lithotomy Mistral Air® Surgical Access Plus (sterile) Mistral Air® Premium Warming Suit M Mistral Air® Warming Suit XL Mistral Air® Premium Paediatric Mistral Air® Adult Plus Mistral Air® Premium Upper Body Fluido® Compact Holder

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility