Data / Medical devices / United States / Uniphar Logistics
Uniphar Logistics: FDA-registered device maker in Garner, NC, United States, 1 510(k) clearance
Uniphar Logistics is registered with the FDA (registration 3027595249) in Garner, NC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027595249
- Address
- 5100 Jones Sausage Rd Ste 130, Garner, NC, United States, 27529
- Owner or operator
- Uniphar Logistics (10092162)
- Roles
- Repackager or relabeler
- First device listed
- March 13, 2026
- Registered through
- 2026
- Brand names listed
- Numen Coil Embolization System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Neurovascular Embolization | HCG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | 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 |
|---|---|---|---|---|---|---|
| September 1, 2021 | K203625 | Numen Coil Embolization System; NumenFR Detachment System | HCG | Substantially Equivalent | MicroPort NeuroTech (Shanghai) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Neurovascular Embolization
- All makers of Device, Vascular, For Promoting Embolization
Updated September 1, 2021. 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.