FDA Registration
Active
🇺🇸 United States
NEMOTO NORTH AMERICA, INC.
Reg #: 3014498725
·
FEI: 3014498725
·
Expires 2026
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEMOTO NORTH AMERICA, INC.
- Registration Number
- 3014498725
- FEI Number
- 3014498725
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 37160 Sugar Ridge Rd
- City
- North Ridgeville
- State
- OH
- ZIP
- 44039
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242212
Owner / Operator
- Firm Name
- Nemoto North America, Inc.
- Operator Number
- 10057761
- Address
- 37160 Sugar Ridge Road
- City
- North Ridgeville
- State
- OH
- Postal Code
- 44039
- Country
- US
- Correspondent
- James Farmer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2024-08-28 |
Proprietary Names
TM0539010
TM0539S
TM0539L
TM0544W
Nemoto Disposable Syringe (Kit)
TM0539K
TM0539AE
Disposable Syringe (Kit)
TM0539P
TM0539M
TM0544C
TM0539003
TM0544W200
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility