Data / Medical devices / Ireland / Biomarin International Limited
Biomarin International Limited: FDA-registered device maker in Ringaskiddy Munster, Ireland, 2 510(k) clearances
Biomarin International Limited is registered with the FDA (registration 3010085632) in Ringaskiddy Munster, Ireland. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 17, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010085632
- Address
- Shanbally, Ringaskiddy Munster, Ireland, P43 R298
- Owner or operator
- BioMarin Pharmaceutical (10054923)
- Roles
- Complaint file establishment, Exporter to the US, Repackager or relabeler
- First device listed
- May 12, 2017
- Registered through
- 2026
- Brand names listed
- Brinuera Administration Kit, Easypoint, Vanishpoint
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Exporter to the US, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 17, 2014 | K133635 | EASYPOINT NEEDLE | FMI | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
| February 12, 1998 | K980069 | VANISHPOINT SYRINGE | MEG | Substantially Equivalent | Retractable Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 17, 2014. 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.