FDA Registration
Active
🇩🇪 Germany
VenSure LightGuide
Reg #: 3010313588
·
FEI: 3010313588
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Fiagon GMBH
- Registration Number
- 3010313588
- FEI Number
- 3010313588
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Neuendorfstr. 23b
- City
- Hennigsdorf Brandenburg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K212774
Owner / Operator
- Firm Name
- Fiagon GmbH
- Operator Number
- 10046786
- Address
- Neuendorfstr. 23b
- City
- Hennigsdorf
- State
- Brandenburg
- Postal Code
- 16761
- Country
- DE
US Agent
- Business Name
- Fiagon NA
- Contact Name
- Matthew Jones
- Address
- 3913 Todd Lane, Suite 101
- City
- Austin
- State
- TX
- ZIP
- 78744
- Country
- US
- [email protected]
- Phone
- 512 3838580
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2022-02-11 |
Proprietary Names
VenSure LightGuide
Establishment Types
Manufacture Medical Device