FDA Registration
Active
🇺🇸 United States
Contour Next Blood Glucose Test Strips
Reg #: 3011121740
·
FEI: 3010700165
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ascensia Diabetes Care US Inc.
- Registration Number
- 3011121740
- FEI Number
- 3010700165
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5 Wood Hollow Road
- City
- Parsippany
- State
- NJ
- ZIP
- 07054
- Country
- US
Regulatory Submissions
- PMA Number
- P150001
Owner / Operator
- Firm Name
- Ascensia Diabetes Care Holdings AG
- Operator Number
- 10050965
- Address
- 5 WOOD HOLLOW RD
- City
- Parsippany
- State
- NJ
- Postal Code
- 07054
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Insulin Dosing , Threshold Suspend | OZO | Class 3 | Unknown | No | 2016-08-11 |
Proprietary Names
Contour Next Blood Glucose Test Strips
Contour Next Link 2.4 Wireless Blood Glucose Monitoring System
Contour Next Link 2.4 Wireless Blood Glucose Meter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility