FDA Registration
Active
🇧🇪 Belgium
G-FLEX EUROPE SRL
Reg #: 3008274780
·
FEI: 3008274780
·
Expires 2026
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- G-FLEX EUROPE SRL
- Registration Number
- 3008274780
- FEI Number
- 3008274780
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 20 Rue de l'Industrie
- City
- Nivelles Brabant Wallon
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K222006
Owner / Operator
- Firm Name
- G-flex Europe Srl
- Operator Number
- 10082053
- Address
- 20 Rue de l'Industrie
- City
- Nivelles
- State
- Brabant Wallon
- Postal Code
- 1400
- Country
- BE
- Correspondent
- Laura Boll
US Agent
- Business Name
- Diversatek Healthcare
- Contact Name
- Laura Boll
- Address
- 102 E Keefe Ave
- City
- Milwaukee
- State
- WI
- ZIP
- 53212
- Country
- US
- [email protected]
- Phone
- 414 7554806
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2021-06-17 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2021-06-10 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2021-06-10 |
| Ligator, Esophageal | MND | Class 2 | Gastroenterology, Urology | No | 2021-06-10 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2023-10-19 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility