FDA Registration
Active
🇯🇵 Japan
PHC Corporation
Reg #: 3004167884
·
FEI: 3004167884
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- PHC Corporation
- Registration Number
- 3004167884
- FEI Number
- 3004167884
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 110 OAZA-INOSHIRI-AZA-NISHIUENO, WAKIMACHI
- City
- MIMA Tokushima
- Country
- JP
Owner / Operator
- Firm Name
- PHC Corporation
- Operator Number
- 9052268
- Address
- 2131-1 MINAMIGATA
- City
- TOON
- State
- Ehime
- Postal Code
- 791-0395
- Country
- JP
- Correspondent
- TOSHIHARU YOSHIOKA
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, Breath Nitric Oxide | MXA | Class 2 | Clinical Toxicology | No | 2018-05-02 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2020-04-07 |
| Automated Insulin Dosing , Threshold Suspend | OZO | Class 3 | Unknown | No | 2020-04-07 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2012-08-09 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2012-08-09 |
| Automated Insulin Dosing Device System, Single Hormonal Control | OZP | Class 3 | Unknown | No | 2017-12-19 |
Proprietary Names
Contour Next, Contour Next Link, Contour Next One
Contour Next Link 2.4
CONTOUR NEXT Test Strip
CONTOUR NEXT ONE Blood Glucose Monitoring System
Contour Next EZ Blood Glucose Meter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)