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Vygon Verneuil: FDA-registered device maker in Verneuil En Halatte Oise, France, 1 510(k) clearance

Vygon Verneuil is registered with the FDA (registration 3011237770) in Verneuil En Halatte Oise, France. It lists 36 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 21, 2003. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3011237770
Address
Parc Alata 5 Avenue des Bouleaux, Verneuil En Halatte Oise, France, 60550
Owner or operator
VYGON S A (8020785)
Roles
Contract sterilizer, Reprocessor
First device listed
February 14, 1997
Registered through
2026
Brand names listed
121, 122, 1361, 1361.xxx, 1362, 1362.1071, 1362.1072, 1362.1271 and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Contract sterilizeraccessdata.fda.gov
Attachment, Breathing, Positive End Expiratory PressureBYE2Contract sterilizer, Reprocessoraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Contract sterilizeraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Contract sterilizeraccessdata.fda.gov
Cannula, A-V ShuntFIQ2Contract sterilizeraccessdata.fda.gov
Cannula, CatheterDQR2Contract sterilizeraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Contract sterilizeraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Contract sterilizeraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS2Contract sterilizeraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Contract sterilizeraccessdata.fda.gov
Catheter, Umbilical ArteryFOS2Contract sterilizeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Contract sterilizeraccessdata.fda.gov
Connector, Airway (Extension)BZA1Contract sterilizeraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Contract sterilizeraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Contract sterilizeraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Contract sterilizeraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Contract sterilizeraccessdata.fda.gov
Enteral Specific Transition ConnectorsPIO2Contract sterilizeraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Contract sterilizeraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Contract sterilizeraccessdata.fda.gov
Introducer, CatheterDYB2Contract sterilizeraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract sterilizeraccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Contract sterilizeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Contract sterilizeraccessdata.fda.gov
Port & Catheter, Implanted, Subcutaneous, IntravascularLJT2Contract sterilizeraccessdata.fda.gov
Port Introducer KitOKE2Contract sterilizeraccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Contract sterilizeraccessdata.fda.gov
Set, Administration, IntravascularFPA2Contract sterilizeraccessdata.fda.gov
Set, Blood TransfusionBRZ2Contract sterilizeraccessdata.fda.gov
Stand, InfusionFOX1Contract sterilizeraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Contract sterilizeraccessdata.fda.gov
Stylet, Tracheal TubeBSR1Contract sterilizeraccessdata.fda.gov
Tube, FeedingFPD2Contract sterilizeraccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Contract sterilizeraccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Contract sterilizeraccessdata.fda.gov
Tubing, Fluid DeliveryFPK2Contract sterilizeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 21, 2003K013884BOUSSIGNAC C.P.A.P. DEVICEBYESubstantially EquivalentVygon SAaccessdata.fda.gov

Compare with other makers

Updated January 21, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.