Beckman Coulter Ireland Inc.
IE-MF-000000887 · Ireland · Co. Clare
Beckman Coulter Ireland Inc. is registered in the European database on medical devices as a manufacturer, with 109 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 66316, 66318, 800-3215, Aquios Lysing Reagent Kit, C49513.
Devices declared under this manufacturer
- (10C 3L) Navios EX Instrument
- Alpha-amylase
- Aquios Lysing Reagent Kit
- Cleaning Solution
- Digitoxin Calibrator
- Digoxin
- EDDP
- HDL/LDL Cholesterol Control Serum
- IRIS
- ISE High Serum Standard
- ISE Reference
- Iris
Showing 12 of 109 declared devices.
Catalogue references include 660-3021, 800-3215, 800-7217, B23538, B80910, C49513.
European nomenclature codes declared: W0202040182, W01010399, W0103080699, W01019099, W0103080101, W0103080403.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Beckman Coulter Ireland Inc (IE) · FDA 9680746 |
| Devices in EUDAMED | 109 |
| Country of registration | Ireland |
Device-level evidence
| Devices with a numeric GTIN | 109 |
|---|---|
| Found in the U.S. device database | 42 |
| Share | 38.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BECKMAN COULTER IRELAND, INC. |
What it holds in Canada
| Licences on record | 26 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 26 |
| First licensed | 2005-04-19 |
Licence types: System (10), Test Kit (10), Device Family (5), Single Device (1).
Licensed under: IQ200 SERIES AUTOMATED URINE MICROSCOPY SYSTEM, NAVIOS FLOW CYTOMETER, NAVIOS ANALYSIS SOFTWARE KITS (FLOW CYTOMETER), ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTE, FLOW CYTOMETER CONTROLS, AQUIOS CL FLOW CYTOMETER SYSTEM.
North American profile: Both markets. Beckman Coulter Ireland Inc. is registered in both the United States and Canada.