FDA Registration
Active
🇺🇸 United States
TRACE1
Reg #: 2245574
·
FEI: 2245574
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NIKOMED U.S.A., INC.
- Registration Number
- 2245574
- FEI Number
- 2245574
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2800 Turnpike Dr
- City
- Hatboro
- State
- PA
- ZIP
- 19040
- Country
- US
Regulatory Submissions
- 510(k) Number
- K022909
Owner / Operator
- Firm Name
- NIKOMED U.S.A., INC.
- Operator Number
- 9023845
- Address
- 2800 Turnpike Drive
- City
- Hatboro
- State
- PA
- Postal Code
- 19040
- Country
- US
- Correspondent
- STEPHEN - EPSTEIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2010-01-05 |
Proprietary Names
TRACE1
Establishment Types
Repack or Relabel Medical Device