FDA Registration Active 🇨🇭 Switzerland

Contour Next Blood Glucose Test Strips

Reg #: 3012118659 · FEI: 3012118659 · Expires 2025
Products
3
Proprietary Names
4
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
K121190

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
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
Glucose Dehydrogenase, Glucose LFR
System, Test, Blood Glucose, Over The Counter NBW

Proprietary Names

Contour Next Blood Glucose Test Strips Contour Next Blood Glucose Monitoring System Contour Next Control Solution Contour Next Blood Glucose Meter

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility