FDA Registration
Active
🇩🇪 Germany
VYGON Germany GmbH
Reg #: 9612433
·
FEI: 3002808464
·
Expires 2026
Products
6
Proprietary Names
17
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- VYGON Germany GmbH
- Registration Number
- 9612433
- FEI Number
- 3002808464
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PRAGER RING 100
- City
- AACHEN North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K993052
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 |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2008-02-02 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2008-02-02 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2012-04-20 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2013-06-28 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2008-02-02 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2015-02-26 |
Proprietary Names
PUR Epicutaneo-Cave Catheter
Leader-flex
Vygon Measuring Tape
Multicath
Epicutaneo-Cava Catheter
Premicath
Vygocard 2
916402
9168.202
Vygon Split Cannula Introducer
Twinflo
Nutriline
Double Taper Connector
Multicath Expert
Lifevac
Leaderflex
Lifecath
Establishment Types
Manufacture Medical Device
Reprocess Single-Use Device