Data / Medical devices / Label Or Tag, Non-Sterile
Label Or Tag, Non-Sterile (QMX): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make Label Or Tag, Non-Sterile (product code QMX, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QMX
- Device class
- 1
- Regulation
- 878.4800
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Costa Rica | 1 |
Makers of Label Or Tag, Non-Sterile
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ATL Technology CR Limitada | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safen | San Antonio, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sigmapro Engineering & Manufacturing, LLC | Fort Worth, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viscot Medical LLC | Denville, NJ, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.