Data / Medical devices / United States / Nuk Usa LLC
Nuk Usa LLC: FDA-registered device maker in Reedsburg, WI, United States, 2 510(k) clearances
Nuk Usa LLC is registered with the FDA (registration 2110540) in Reedsburg, WI, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 5, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2110540
- FEI number
- 3007429416
- Address
- 728 Booster BLVD., Reedsburg, WI, United States, 53959
- Owner or operator
- NUK USA, LLC (10028598)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 16, 2009
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Specification developer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Complaint file establishment | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Complaint file establishment | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Complaint file establishment | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 5, 2013 | K121478 | NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP | HGX | Substantially Equivalent | Mapa GmbH | accessdata.fda.gov |
| September 17, 2010 | K101157 | E-BASIC SINGLE BREAST PUMP | HGX | Substantially Equivalent | Mapa GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Breast, Powered
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
- All makers of Ring, Teething, Non-Fluid Filled
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Fiber, Medical, Absorbent
- All makers of Pump, Breast, Non-Powered
Updated April 5, 2013. 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.