FDA Registration
Active
🇯🇵 Japan
PRESS DUO elite
Reg #: 9616990
·
FEI: 3008918179
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEMOTO KYORINDO CO., LTD.
- Registration Number
- 9616990
- FEI Number
- 3008918179
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2-12-23 Aoki, Kawaguchi Plant
- City
- KAWAGUCHI-SHI Saitama
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K173450
Owner / Operator
- Firm Name
- NEMOTO KYORINDO CO., LTD.
- Operator Number
- 9043772
- Address
- 2-27-20 HONGO, (HONGO CTR. BLDG. 3RD FLOOR)
- City
- BUNKYO-KU
- State
- Tokyo
- Postal Code
- 113-0033
- Country
- JP
- Correspondent
- JIM E KNIPFER
US Agent
- Business Name
- NEMOTO MEDICAL U.S., INC.
- Contact Name
- MICHAEL HIEDA
- Address
- 24992 DEL MONTE ST.
- City
- LAGUNA HILLS
- State
- CA
- ZIP
- 92653
- Country
- US
- [email protected]
- Phone
- 949 6326183 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2018-02-21 |
Proprietary Names
PRESS DUO elite
PRESS DUO elite AG
Establishment Types
Manufacture Medical Device