FDA Registration
Active
🇯🇵 Japan
Supercath 5
Reg #: 3014270673
·
FEI: 3014270673
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Togo Medikit Co., Ltd. Medikit Hyuga Second Factory
- Registration Number
- 3014270673
- FEI Number
- 3014270673
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 435-3, Hei, Aza Kakinokida, Yamage, Togo-cho,
- City
- Hyuga City Miyazaki
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K190001
Owner / Operator
- Firm Name
- TOGO MEDIKIT CO., LTD.
- Operator Number
- 8030371
- Address
- 17148-6 AZA KAMEKAWA, OAZA HICHIYA
- City
- HYUGA CITY
- State
- Miyazaki
- Postal Code
- 883-0062
- Country
- JP
- Correspondent
- TAKASHI - NAKAJIMA
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2020-02-28 |
Proprietary Names
Supercath 5
Establishment Types
Manufacture Medical Device