Data / Medical devices / United States / Brandzig
Brandzig: FDA-registered device maker in Spring Valley, NY, United States, 1 510(k) clearance
Brandzig is registered with the FDA (registration 3012187743) in Spring Valley, NY, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012187743
- Address
- 20 Garden Terrace, Spring Valley, NY, United States, 10977
- Owner or operator
- Brandzig (10054359)
- Roles
- Repackager or relabeler
- First device listed
- March 10, 2017
- Registered through
- 2026
- Brand names listed
- Syringe 3
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Antistick | MEG | 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 2, 2021 | K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | MEG | Substantially Equivalent | Jiangsu Micsafe Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dispenser, Liquid Medication
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Antistick
Updated July 2, 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.