Data / Medical devices / United States / Asmoh Usa Inc
Asmoh Usa Inc: FDA-registered device maker in Sunrise, FL, United States, 2 510(k) clearances
Asmoh Usa Inc is registered with the FDA (registration 3029755538) in Sunrise, FL, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 18, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029755538
- Address
- 12054 Miramar PRWY, Sunrise, FL, United States, 33325
- Owner or operator
- ASMOH USA INC (10089012)
- Roles
- Repackager or relabeler
- First device listed
- March 14, 2024
- Registered through
- 2026
- Brand names listed
- ASMOH SYRINGES AND SAFETY NEEDLES
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 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 |
|---|---|---|---|---|---|---|
| July 18, 2023 | K222925 | Hypodermic Syringes & Needle | FMF | Substantially Equivalent | Lifelong Meditech Private Limited | accessdata.fda.gov |
| July 16, 2021 | K210103 | SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX | FMF | Substantially Equivalent | Lifelong Meditech Private Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Antistick
Updated July 18, 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.