FDA Registration
Active
🇨🇭 Switzerland
Contour Next Control Solutions
Reg #: 3012118659
·
FEI: 3012118659
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ASCENSIA DIABETES CARE HOLDINGS AG
- Registration Number
- 3012118659
- FEI Number
- 3012118659
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Peter Merian-Strasse 90
- City
- Basel Basel-Stadt
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K191286
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 |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2019-11-15 |
Proprietary Names
Contour Next Control Solutions
Contour Next USB Blood Glucose Monitoring System
Contour Next LINK Wireless Blood Glucose Monitoring System
Contour Next LINK Wireless Blood Glucose Meter
Contour Next ONE Blood Glucose Meter
Contour Next Blood Glucose Monitoring System
Contour Next EZ Blood Glucose Meter
Contour Next Blood Glucose Meter
Contour Next EZ Blood Glucose Monitoring System
Contour Next ONE Blood Glucose Monitoring System
Contour Next Blood Glucose Test Strips
Contour Next USB Blood Glucose Meter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility