FDA Registration
Active
🇯🇵 Japan
TOGO MEDIKIT CO., LTD.
Reg #: 9612126
·
FEI: 3002807548
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- TOGO MEDIKIT CO., LTD.
- Registration Number
- 9612126
- FEI Number
- 3002807548
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 17148-6 AZA KAMEKAWA, OAZA HICHIYA
- City
- HYUGA CITY Miyazaki
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K121504
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 |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2012-12-06 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2012-12-06 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2020-10-29 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2020-02-28 |
| Catheter, Peritoneal | GBW | Class 1 | General, Plastic Surgery | No | 2021-04-05 |
Proprietary Names
Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Set
SUPER SHEATH XL INTRODUCER SHEATH
Mongoose Angiographic Catheter
Super Sheath R/O
Super Sheath
Super Sheath, Super Sheath R/O
Supercath 5
Supercath5
Super Sheath CBDE
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device