FDA Registration
Active
🇩🇪 Germany
Leader-flex
Reg #: 9612433
·
FEI: 3002808464
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VYGON Germany GmbH
- Registration Number
- 9612433
- FEI Number
- 3002808464
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PRAGER RING 100
- City
- AACHEN North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K052564
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, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2008-02-02 |
Proprietary Names
Leader-flex
Establishment Types
Manufacture Medical Device