EKF-diagnostic GmbH
DE-MF-000006416 · Germany · Barleben
EKF-diagnostic GmbH is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- Cleaner
- CompoLab TM Plus
- DiaSpect Control Pack HBT1
- DiaSpect Control Pack HBT2
- DiaSpect Control Pack HBT3
- DiaSpect Control Pack HBT4
- DiaSpect Tm
- Hb-con Set 2
- Hb-con high
- Hb-con low
- Hb-con norm
- Hemo Control Hemoglobin Microcuvette
Showing 12 of 17 declared devices.
Catalogue references include 3000-3112-01, 3000-3112-0765, 3000-6222, 3000-6233, 3200-6111, 3200-6112.
European nomenclature codes declared: W0103010504, W0103010601, W0201010185, W0202010202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EKF DIAGNOSTIC GMBH (DE) · FDA 3004838836 |
| Devices in EUDAMED | 17 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 17 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 5.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | EKF-DIAGNOSTIC GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2010-04-19 |
Licence types: System (1).
Licensed under: DIASPECT HEMOGLOBIN.
North American profile: Both markets. EKF-diagnostic GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
V76 044132 0027 | issued | 2031-06-23 |
V76 044132 0026 | supplemented | 2030-10-22 |