Aesku.Diagnostics GmbH & Co. KG
DE-MF-000026925 · Germany · Wendelsheim
Aesku.Diagnostics GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 162 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 20110007, 20110008, 20110009.
Devices declared under this manufacturer
- AESKUBLOTS® ANA-17 comp
- AESKUBLOTS® Allergy FOUR
- AESKUBLOTS® Food Intolerance FIFTY-FOUR
- AESKUBLOTS® Food Intolerance FIVE
- AESKUBLOTS® Food Intolerance FOUR
- AESKUBLOTS® Food Intolerance ONE
- AESKUBLOTS® Food Intolerance SEVEN
- AESKUBLOTS® Food Intolerance SIX
- AESKUBLOTS® Gluten Related Disorders IgA
- AESKUBLOTS® Gluten Related Disorders IgG
- AESKULISA® ANA-8S
- AESKULISA® MMP-3
Showing 12 of 162 declared devices.
Catalogue references include 3100, 4008, 401005, 401006, 421004, 431401.BULK120.
European nomenclature codes declared: W01020204, W0102010106, W0102100101, W0102152011, W0102109099, W0102100107.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AESKU.DIAGNOSTICS GmbH&Co.KG (DE) · FDA 3003825930 |
| Devices in EUDAMED | 162 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 162 |
|---|---|
| Found in the U.S. device database | 22 |
| Share | 13.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AESKU.DIAGNOSTICS GMBH & CO. KG |
What it holds in Canada
| Licences on record | 38 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 38 |
| First licensed | 2008-04-11 |
Licence types: Test Kit (31), Device Family (4), System (2), Single Device (1).
Licensed under: AESKULISA TTG-A (TISSUE TRANSGLUTAMINASE IGA), AESKULISA ANA HEP2, AESKULISA DSDNA-G, AESKULISA ENA-6S (EXTRACTABLE NUCLEAR ANTIGEN), AESKULISA CARDIOLIPIN - GM, AESKULISA MPO.
North American profile: Both markets. Aesku.Diagnostics GmbH & Co. KG is registered in both the United States and Canada.