EPflex Feinwerktechnik GmbH
DE-MF-000005425 · Germany · Dettingen an der Erms
EPflex Feinwerktechnik GmbH is registered in the European database on medical devices as a manufacturer, with 322 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 232 |
|---|---|
| Class I | 90 |
Among these devices, 321 are declared sterile.
Devices declared under this manufacturer
- Dashwire
- Dormia Front
- Equadus
- IMP Führungsdraht
- IMP Katheterwechsel Führungsdraht
- IMP Litholapixie-Führungsdraht
- IMP PTFE Führungsdraht
- IMP PTFE Guidewire
- IMP PTFE-Führungsdraht
- Meridian
- NiTAN
- SemiSlip
Showing 12 of 322 declared devices.
Catalogue references include 139701032150, 41010092, 41013240, 41013241, 47005439, AU-035-220-C.
European nomenclature codes declared: U0602, C0499, U090101, U0601, G030499, C04010202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EPFLEX FEINWERKTECHNIK GMBH (DE) · FDA 3003289691 |
| Devices in EUDAMED | 322 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 258 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. EPflex Feinwerktechnik GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000266008 | issued | 2029-07-02 |
1000265993 | issued | 2028-11-08 |