Data / Medical devices / United States / MEDIPOINT Holdings, LLC
MEDIPOINT Holdings, LLC: FDA-registered device maker in Mineola, NY, United States, 1 510(k) clearance
MEDIPOINT Holdings, LLC is registered with the FDA (registration 2416465) in Mineola, NY, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2416465
- Address
- 72 East 2ND ST., Mineola, NY, United States, 11501
- Owner or operator
- MEDIpoint Holdings, LLC. (2416465)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 16, 2022
- Registered through
- 2026
- Brand names listed
- Medipoint Blood Lancets, Medipoint Stainless Steel Blade, SPLINTER OUT, Splinter Out
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Scalpel | GES | 1 | Manufacturer | accessdata.fda.gov |
| Curette | HTF | 1 | Manufacturer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 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 |
|---|---|---|---|---|---|---|
| January 13, 2023 | K223480 | Medipoint Blood Lancets | QRK | Substantially Equivalent | Medipoint Holdings, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of First Aid Kit With Drug
- All makers of Blade, Scalpel
- All makers of Curette
Updated January 13, 2023. 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.