FDA Registration
Active
🇯🇵 Japan
OMRON HEALTHCARE CO., LTD.
Reg #: 8030245
·
FEI: 3004072282
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OMRON HEALTHCARE CO., LTD.
- Registration Number
- 8030245
- FEI Number
- 3004072282
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kunotsubo 53, Terado-Cho
- City
- MUKO Kyoto
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K182166
Owner / Operator
- Firm Name
- OMRON HEALTHCARE CO., LTD.
- Operator Number
- 8030246
- Address
- 53, Kunotsubo, Terado-cho
- City
- MUKO
- State
- Kyoto
- Postal Code
- 617-0002
- Country
- JP
US Agent
- Business Name
- OMRON HEALTHCARE, INC.
- Contact Name
- Terri Ingalls
- Address
- 2895 Greenspoint Parkway, Suite 100
- City
- Hoffman Estates
- State
- IL
- ZIP
- 60169
- Country
- US
- [email protected]
- Phone
- 847 2475657
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-05-08 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility