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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2012-01-13 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2015-08-31 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2008-02-02 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2018-06-19 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2018-06-19 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2025-01-14 |
| Cannula, Catheter | DQR | Class 2 | Cardiovascular | No | 2014-01-24 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2008-01-03 |
| Set, Blood Transfusion | BRZ | Class 2 | General Hospital | No | 2015-01-08 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2016-05-13 |
| Catheter, Umbilical Artery | FOS | Class 2 | General Hospital | No | 2012-03-26 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2018-06-19 |
| Port Introducer Kit | OKE | Class 2 | General Hospital | No | 2018-06-19 |
| Enteral Syringes With Enteral Specific Connectors | PNR | Class 2 | Gastroenterology, Urology | No | 2025-02-24 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2015-08-31 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2017-12-13 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2007-08-06 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2012-03-26 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2015-06-10 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2012-03-26 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2008-02-02 |
| Enteral Specific Transition Connectors | PIO | Class 2 | Gastroenterology, Urology | No | 2016-07-20 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2015-01-08 |
| Cannula, A-V Shunt | FIQ | Class 2 | Gastroenterology, Urology | No | 2016-07-20 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2007-08-06 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2014-08-18 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2008-02-02 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2016-07-20 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2005-10-05 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2015-08-31 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2005-11-29 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2012-03-26 |
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)