FDA Registration
Active
🇩🇪 Germany
EPFLEX FEINWERKTECHNIK GMBH
Reg #: 3003289691
·
FEI: 3003289691
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- EPFLEX FEINWERKTECHNIK GMBH
- Registration Number
- 3003289691
- FEI Number
- 3003289691
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- IM SCHWOELLBOGEN 24
- City
- DETTINGEN/ERMS Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- EPFLEX FEINWERKTECHNIK GMBH
- Operator Number
- 9087185
- Address
- IM SCHWOELLBOGEN 24, --
- City
- DETTINGEN/ERMS
- State
- Baden-Wurttemberg
- Postal Code
- D 72581
- Country
- DE
- Correspondent
- Dr. Johannes - Uihlein
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2025-11-28 |
| Wire, Guide, Catheter, Exempt | PTL | Class 2 | Cardiovascular | No | 2020-04-07 |
| Dislodger, Stone, Flexible | FGO | Class 2 | Gastroenterology, Urology | No | 2009-09-14 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2024-12-05 |
| Stylet, Ureteral | EYA | Class 1 | Gastroenterology, Urology | No | 2015-02-11 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2009-09-14 |
Proprietary Names
Prelude Small O.D. Introducer Guide Wire
Soprano® Dual Flex PTFE-Nitinol Guidewire with Straight Hydrophilic Tip
Soprano® PTFE-Nitinol Guidewire with Straight Hydrophilic Tip
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device