IBL International GmbH
DE-MF-000015709 · Germany · Hamburg
IBL International GmbH is registered in the European database on medical devices as a manufacturer, with 148 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- Amyloid-beta (1-42) CSF ELISA
- Androstenedione ELISA
- Borrelia + VlsE IgG ELISA
- Dopamine ELISA
- Melatonin-Sulfate Urine ELISA
- Renin (active) IRMA (CT)
- SS-B/La-Ab ELISA
- SaliCap Set
- Serotonin ELISA
- Testosterone RIA (CT)
- Transglutaminase IgA ELISA
- Transglutaminase IgG ELISA
Showing 12 of 148 declared devices.
Catalogue references include 30132293, DB52161, MG11101, RE54031, RE57201, RE69981.
European nomenclature codes declared: W0102050110, W0102050102, W0102060601, W0102050106, W0102050103, W0102069003.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | IBL INTERNATIONAL GMBH (DE) · FDA 9710337 |
| Devices in EUDAMED | 148 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 148 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 4.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | IBL INTERNATIONAL GMBH |
What it holds in Canada
| Licences on record | 20 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 20 |
| First licensed | 2007-11-21 |
Licence types: Test Kit (20).
Licensed under: 17-OH-PROGESTERONE ELISA, ACETYLCHOLINE RECEPTOR AUTOANTIBODIES (ARAB) R, SEROTONIN ELISA, MELATONIN-SULFATE URINE ELISA, MELATONIN ELISA, HISTAMINE ELISA.
North American profile: Both markets. IBL International GmbH is registered in both the United States and Canada.