FDA Registration Active 🇯🇵 Japan

CONTOUR NEXT Test Strip

Reg #: 3014353045 · FEI: 3014353045 · Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1

Registration Details

Registration Name
PHC Corporation
Registration Number
3014353045
FEI Number
3014353045
Status
Active
Expiry Year
2025
Initial Importer
No
Address
15F DAI-ICHI LIFE HIBIYA FIRST, 1-13-2 Yurakucho
City
Chiyoda-ku Tokyo
Country
JP

Regulatory Submissions

PMA Number
P160017

Owner / Operator

Firm Name
PHC Corporation
Operator Number
9052268
Address
2131-1 MINAMIGATA
City
TOON
State
Ehime
Postal Code
791-0395
Country
JP

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
Phone
551 4829284

Products

Device Name Product Code
Automated Insulin Dosing Device System, Single Hormonal Control OZP

Proprietary Names

CONTOUR NEXT Test Strip Contour Next Link 2.4

Establishment Types

Export Device to the United States But Perform No Other Operation on Device