FDA Registration
Active
🇨🇭 Switzerland
Glucofacts Deluxe Diabetes Management System
Reg #: 3012118659
·
FEI: 3012118659
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
- K091820
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 |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2016-01-21 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2016-01-21 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2016-01-21 |
Proprietary Names
Glucofacts Deluxe Diabetes Management System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility