FDA Registration
Active
🇺🇸 United States
Ascensia Diabetes Care US Inc.
Reg #: 1810909
·
FEI: 1810909
·
Expires 2026
Products
10
Proprietary Names
42
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- Ascensia Diabetes Care US Inc.
- Registration Number
- 1810909
- FEI Number
- 1810909
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 Summit Lake Drive
- City
- Valhalla
- State
- NY
- ZIP
- 10595
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091820
- 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 |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2016-01-21 |
| 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 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2022-11-18 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2016-01-21 |
| Automated Insulin Dosing , Threshold Suspend | OZO | Class 3 | Unknown | No | 2016-08-11 |
| 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 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 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 |
Proprietary Names
Glucofacts Deluxe Diabetes Management System
Contour Next EZ Blood Glucose Monitoring System
Contour Next EZ Blood Glucose Meter
Contour Next Blood Glucose Test Strips
MICROLET NEXT lancing device, MICROLET Lancet
Contour Next Link Wireless Blood Glucose Meter
Contour Next Control Solution
CONTOUR® NEXT GEN Blood Glucose Monitoring System
Contour Next Link 2.4 Wireless Blood Glucose Monitoring System
Contour Next Link 2.4 Wireless Blood Glucose Meter
Diastix
Keto-Diastix
Contour Next ONE Blood Glucose Monitoring System
CONTOUR PLUS LINK 2.4
CONTOUR NEXT LINK 2.4
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
Contour Next Blood Glucose Monitoring System
Contour Next Blood Glucose Meter
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® NEXT ONE Blood Glucose Monitoring System
Contour® next GEN Blood Glucose Monitoring System
Ketostix, Keto-Diastix
Contour Control Solution
CONTOUR NEXT ONE
CONTOUR PLUS
CONTOUR NEXT
CONTOUR NEXT LINK
CONTOUR NEXT EZ
CONTOUR PLUS ONE
CONTOUR PLUS LINK
Glucofacts Deluxe Diabetes Management Software
Contour
Contour TS
MICROLET®NEXT Lancets
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198