FDA Registration
Active
🇯🇵 Japan
Sanamedi, Inc.
Reg #: 3010805418
·
FEI: 3010805418
·
Expires 2026
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sanamedi, Inc.
- Registration Number
- 3010805418
- FEI Number
- 3010805418
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #601 Nihonbashi Life Science Building, 2-3-11 Nihonbashi-Honcho
- City
- Chuo-ku Tokyo
- Country
- JP
Owner / Operator
- Firm Name
- Sanamedi, Inc.
- Operator Number
- 10046345
- Address
- 601 Nihonbashi LIfe Science Building, 2-3-11 Nihonbashi-Honcho, Chuo-ku
- City
- Tokyo
- State
- JP-13
- Postal Code
- 103-0023
- Country
- JP
- Correspondent
- Takahiro Uchida
US Agent
- Business Name
- 510K Technology Group LLC
- Contact Name
- Kachi Enyinna
- Address
- 1337 Mass Ave, #286
- City
- Arlington
- State
- MA
- ZIP
- 02476
- Country
- US
- [email protected]
- Phone
- 617 8704055
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 2014-03-10 |
Proprietary Names
OZAKI VRec Sizer (13mm, 15mm, 17mm)
OZAKI VRec Sizer System (19mm, 21mm, 23mm, 25mm, 27mm, 29mm, 31mm, 33mm, 35mm)
OZAKI AVNeo(R) Sizer System
OZAKI AVNeo(R) Sizer (31, 33, 35)
Heart Valve Sizer and Template
OZAKI AVNeo(R) Sizer (13, 15, 17)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility