FDA Registration Active 🇫🇷 France

VYGON S A

Reg #: 8020785 · FEI: 3009291251 · Expires 2026
Products
32
Proprietary Names
107
Establishment Types
4
Classifications
32

Registration Details

Registration Name
VYGON S A
Registration Number
8020785
FEI Number
3009291251
Status
Active
Expiry Year
2026
Initial Importer
No
Address
5-11 RUE ADELINE
City
ECOUEN 95440 Val-d'Oise
Country
FR

Regulatory Submissions

510(k) Number
K813360

Owner / Operator

Firm Name
VYGON S A
Operator Number
8020785
Address
5-11 RUE ADELINE, --
City
ECOUEN
State
FR-NOTA
Postal Code
95440
Country
FR
Correspondent
Chris Steinke

Products

Device Name Product Code
Drape, Surgical, Antimicrobial KKX
Dispenser, Liquid Medication KYX
Tubes, Gastrointestinal (And Accessories) KNT
Needle, Hypodermic, Single Lumen FMI
Set, Administration, Intravascular FPA
Tube, Feeding FPD
Cannula, Catheter DQR
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Set, Blood Transfusion BRZ
Cannula, Nasal, Oxygen CAT
Catheter, Umbilical Artery FOS
Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
Port Introducer Kit OKE
Enteral Syringes With Enteral Specific Connectors PNR
Kit, Surgical Instrument, Disposable KDD
Tourniquet, Nonpneumatic GAX
Instrument, Ent Manual Surgical LRC
Tube, Tracheal (W/Wo Connector) BTR
Device, Intravascular Catheter Securement KMK
Catheter, Intravascular, Diagnostic DQO
Catheters, Suction, Tracheobronchial BSY
Enteral Specific Transition Connectors PIO
Bedding, Disposable, Medical KME
Cannula, A-V Shunt FIQ
Stylet, Tracheal Tube BSR
Regulator, Pressure, Gas Cylinder CAN
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Introducer, Catheter DYB
Attachment, Breathing, Positive End Expiratory Pressure BYE
Stand, Infusion FOX
Strap, Head, Gas Mask BTK
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL

Proprietary Names

Dermafilm Nutrisafe 2 Vygon PUR Enteral Feeding Tubes Polyperf Nutrifit Enteral Feeding Tube - Closed tip-PUR-1366.Xxx 368.xxxx 1362.xxx 1364.xxx 362.xxx 363.xxx 361.xxx 1363.xxx 1361.xxx 368.xxx 366.xxx 364.xxx 1366.xxx Nutrifit Enteral Feeding Tube-PVC 366.Xxx Intraflon 2 122 121 Latex-Free Bionector Vygon Exchange Transfusion Tray 275.xxx Nasal Oxygen Catheter XRO Gastro-Duodenal Dual Flow Salem Type Feeding Tube 1362871 1362.1271 1362.1671 1366671 1362.1072 1366.1871 1362671 1362.1272 1362.1471 1366871 1366.1271 1366872 1366.1072 1362.1871 1366.1272 1362872 1366.1471 1362.1071 1366.1671 81757 1362 1364 1361 361 364 8187 817.207 82887 1363 817572 NUTRIFIT SAMPLING STRAW 339172 NUTRIFIT 36897 368.47 82817 362 363 817.208 368.1572 817.157 58027 Vygon XRO PVC Venous/Arterial Umbilical Catheter Polysite Vygon Multi-Dose Vial Adaptor and Bionector Nutrifit/ENFit Enteral Syringe with cap -1015.Xxxx Thoracic trocar and drain Vene-K BOUGIE BOUSSIGNAC PPS PI Vygon Double Lumen Endotracheal Tube Grip-Lok Leader-Cath Nutrisafe Silicone Enteral Feeding Tubes Leaderflex PVC Enteral Feeding Tubes Mucaid Vygon NeoSump Gastric Aspirator PUR Umbilical Catheter Nutrisafe 2 - ENFit Adaptor Lectospiral NeoHelp Hemoclav TRACHEOBRONCHIAL CATHETERS Vygon PVC Umbilical Catheter Lectrocath Caps and Connectors Bionector BOUGIE BOUSSIGNAC T Vygon PVC XRO Venous/Arterial Umbilical Catheter FiO2 Adaptor Ring Vygon Spinal Anesthesia Needle w/ Introducer Vygon Double Lumen Umbilical Catheter Boussignac Desilet BOUSSIGNAC C.P.A.P. DEVICE FIXATION HARNESS FOR FACIAL MASK Delee Vyclic

Establishment Types

Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Sterilize Medical Device for Another Party (Contract Sterilizer)