HORIBA ABX SAS
FR-MF-000000320 · France · MONTPELLIER Cedex 4
HORIBA ABX SAS is registered in the European database on medical devices as a manufacturer, with 216 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 0903010, 0904011, 1300036385, 1300036412, 1300080584.
Devices declared under this manufacturer
- 4 ML REAGENT CUP
- ABX Fluocyte 0.5L
- ABX Miniclean 1L
- ABX Pentra CRP Cal
- ABX Pentra Dummy-E
- ABX Pentra Etching CP
- ABX Pentra Lipase CP
- ABX Pentra Urinary Proteins CP
- Yumizen C Glucose PAP
- Yumizen C Phosphorus
- Yumizen Compressor
- Yumizen G CTRL I & II
Showing 12 of 216 declared devices.
Catalogue references include 0403010, 0904011, 1300036385, 1300036412, 1300080584, 1300141443.
European nomenclature codes declared: W0103010103, W0103010503, W0202010101, W0202010102, W0202020102, W0101050302.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HORIBA ABX SAS (FR) · FDA 3000148879 |
| Devices in EUDAMED | 216 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 216 |
|---|---|
| Found in the U.S. device database | 103 |
| Share | 47.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HORIBA ABX SAS |
What it holds in Canada
| Licences on record | 19 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 19 |
| First licensed | 2006-12-19 |
Licence types: System (7), Single Device (7), Device Family (5).
Licensed under: C-REACTIVE PROTEIN CALIBRATOR, RETICULOCYTE CONTROLS, WHOLE BLOOD HEMATOLOGY CALIBRATOR, HEMATOLOGY ANALYZERS, WHOLE BLOOD CBC CONTROLS, ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM.
North American profile: Both markets. HORIBA ABX SAS is registered in both the United States and Canada.