FDA Registration
Active
🇨🇭 Switzerland
ASCENSIA DIABETES CARE HOLDINGS AG
Reg #: 3012118659
·
FEI: 3012118659
·
Expires 2026
Products
10
Proprietary Names
42
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- ASCENSIA DIABETES CARE HOLDINGS AG
- Registration Number
- 3012118659
- FEI Number
- 3012118659
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Peter Merian-Strasse 90
- City
- Basel Basel-Stadt
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K110894
- PMA Number
- P160017
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 |
|---|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2016-01-21 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2016-01-21 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2016-01-21 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2016-01-21 |
| Automated Insulin Dosing Device System, Single Hormonal Control | OZP | Class 3 | Unknown | No | 2017-12-14 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2022-11-18 |
| Automated Insulin Dosing , Threshold Suspend | OZO | Class 3 | Unknown | No | 2020-04-03 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2016-01-21 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2026-03-11 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2016-01-21 |
Proprietary Names
Contour Next Link Wireless Blood Glucose Meter
Contour Next Blood Glucose Test Strips
Contour Next Control Solution
Contour Next Blood Glucose Monitoring System
Contour Next Blood Glucose Meter
Diastix
Keto-Diastix
Contour Next Link 2.4 Wireless Blood Glucose Meter
Contour Next ONE Blood Glucose Monitoring System
Contour
Contour TS
Contour Next EZ Blood Glucose Monitoring System
Contour Next EZ Blood Glucose Meter
MICROLET NEXT lancing device, MICROLET Lancet
CONTOUR PLUS LINK 2.4
CONTOUR NEXT LINK 2.4
Glucofacts Deluxe Diabetes Management System
CONTOUR NEXT ONE
CONTOUR PLUS
CONTOUR NEXT
CONTOUR NEXT LINK
CONTOUR NEXT EZ
CONTOUR PLUS ONE
CONTOUR PLUS LINK
MICROLET®NEXT Lancets
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
Contour® next GEN Blood Glucose Monitoring System
Contour Next Control Solutions
Contour Next USB Blood Glucose Monitoring System
Contour Next USB Blood Glucose Meter
Contour Next LINK Wireless Blood Glucose Meter
Contour Next LINK Wireless Blood Glucose Monitoring System
Contour Next ONE Blood Glucose Meter
Contour Next Link Blood Glucose Meter
Contour Next Link Blood Glucose Monitoring System
Contour Control Solution
Ketostix, Keto-Diastix
CONTOUR® NEXT GEN Blood Glucose Monitoring System
CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
Glucofacts Deluxe Diabetes Management Software
Contour Next Link 2.4 Wireless Blood Glucose Monitoring System
CONTOUR® NEXT ONE Blood Glucose Monitoring System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility