Data / Medical devices / Netherlands / Acist Europe BV
Acist Europe BV: FDA-registered device maker in Heerlen Limburg, Netherlands, 4 510(k) clearances
Acist Europe BV is registered with the FDA (registration 3012044688) in Heerlen Limburg, Netherlands. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 13, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012044688
- Address
- Argonstraat 3, Heerlen Limburg, Netherlands, 6422PH
- Owner or operator
- ACIST Europe BV (10084954)
- Roles
- Exporter to the US, Foreign private label distributor
- First device listed
- April 20, 2022
- Registered through
- 2026
- Brand names listed
- Empower CTA Injector System, EmpowerCTA+ Injector System, EmpowerMR Injector System, FastLoad CTA dual Syringe Pack
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 2 | Exporter to the US | accessdata.fda.gov |
| Injector, Contrast Medium, Automatic | IZQ | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Plethysmograph, Impedance | DSB | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Pump, Infusion Or Syringe, Extra-Luminal | FIH | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Foreign private label distributor | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 13, 2007 | K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | IZQ | Substantially Equivalent | E-Z-Em, Inc. | accessdata.fda.gov |
| January 27, 1998 | K974621 | PERCUPUMP II WITH EDA | DSB | Substantially Equivalent | E-Z-Em, Inc. | accessdata.fda.gov |
| March 21, 1995 | K932055 | PERCUPUMP II | FIH | Substantially Equivalent | E-Z-Em, Inc. | accessdata.fda.gov |
| December 13, 1994 | K933846 | ANGIOGRAPHY SYRINGE KITS | DXT | Substantially Equivalent | Angiodynamics, Div. E-Z-Em, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Injector, Contrast Medium, Automatic
- All makers of Plethysmograph, Impedance
- All makers of System, X-Ray, Tomography, Computed
- All makers of Injector And Syringe, Angiographic
Updated April 13, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.