FDA Registration
Active
🇯🇵 Japan
CONTOUR NEXT Test Strip
Reg #: 1000134386
·
FEI: 1000134386
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PHC Corporation
- Registration Number
- 1000134386
- FEI Number
- 1000134386
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2131-1 MINAMIGATA
- City
- TOON Ehime
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K191286
Owner / Operator
- Firm Name
- PHC Corporation
- Operator Number
- 9052268
- Address
- 2131-1 MINAMIGATA
- City
- TOON
- State
- Ehime
- Postal Code
- 791-0395
- Country
- JP
- Correspondent
- KAZUHIRO MATSUMOTO
US Agent
- Business Name
- PHC CORPORATION OF NORTH AMERICA
- Contact Name
- Steven Hubbard
- Address
- 1300 MICHAEL DR , STE A
- City
- Wood Dale
- State
- IL
- ZIP
- 60191
- Country
- US
- [email protected]
- Phone
- 551 4829284
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2019-11-15 |
Proprietary Names
CONTOUR NEXT Test Strip
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)