Data / Medical devices / Ireland / embecta Penel Limited
embecta Penel Limited: FDA-registered device maker in Dun Laoghaire Co. Dublin(County), Ireland, 3 510(k) clearances
embecta Penel Limited is registered with the FDA (registration 3023359743) in Dun Laoghaire Co. Dublin(County), Ireland. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated December 28, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3023359743
- Address
- Pottery Road, Dun Laoghaire Co. Dublin(County), Ireland, -
- Owner or operator
- embecta Corp. (10084714)
- Roles
- Manufacturer
- First device listed
- October 18, 2022
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 28, 2022 | K223286 | BD AutoShield Duo Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 28, 2022 | K213478 | BD Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 19, 2021 | K212015 | BD Nano 2nd Gen Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
Compare with other makers
Updated December 28, 2022. 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.