FDA Registration
Active
🇺🇸 United States
NUK USA LLC
Reg #: 2110540
·
FEI: 3007429416
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
4
Classifications
7
Registration Details
- Registration Name
- NUK USA LLC
- Registration Number
- 2110540
- FEI Number
- 3007429416
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 728 BOOSTER BLVD.
- City
- Reedsburg
- State
- WI
- ZIP
- 53959
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101157
Owner / Operator
- Firm Name
- NUK USA, LLC
- Operator Number
- 10028598
- Address
- 728 Booster Blvd
- City
- Reedsburg
- State
- WI
- Postal Code
- 53959
- Country
- US
- Correspondent
- Fred Roeder
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ring, Teething, Non-Fluid Filled | MEF | Class 1 | Dental | No | 2009-11-13 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2010-12-13 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2009-02-16 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2009-02-16 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2011-06-06 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2015-12-29 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2009-06-17 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device