Data / Medical devices / United States / Meret Usa LLC
Meret Usa LLC: FDA-registered device maker in Newport Beach, CA, United States, 2 510(k) clearances
Meret Usa LLC is registered with the FDA (registration 3021841055) in Newport Beach, CA, United States. It lists 15 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 26, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021841055
- Address
- 151 Shipyard Way, Suite B, Newport Beach, CA, United States, 92663
- Owner or operator
- MERET USA LLC (10084520)
- Roles
- Repackager or relabeler
- First device listed
- March 4, 2022
- Registered through
- 2027
- Brand names listed
- MERET
Devices it lists
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 26, 2024 | K233598 | Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | LZA | Substantially Equivalent | Anhui Intco Medical Products Co., Ltd. | accessdata.fda.gov |
| February 10, 2022 | K211570 | Zeolite Hemostatic Gauze | QSY | Substantially Equivalent | Hangzhou Zeo-Innov Life Technology Co., Ltd. | accessdata.fda.gov |
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Updated January 26, 2024. 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.