Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012118659

FEI Number

3012118659

Entity Name

ASCENSIA DIABETES CARE HOLDINGS AG

City/State/Country

Basel Basel-Stadt, CH

Establishment Address

Peter Merian-Strasse 90, Basel Basel-Stadt CH-4052, CH

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Ascensia Diabetes Care Holdings AG (Owner Number: 10050965)

Owner / Operator Contact Address

5 WOOD HOLLOW RD, Parsippany, NJ 07054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Contour Next Link Wireless Blood Glucose Meter Contour Next Blood Glucose Test Strips Contour Next Control Solution Contour Next Link Wireless Blood Glucose Meter Contour Next Blood Glucose Test Strips Contour Next Blood Glucose Test Strips Contour Next Blood Glucose Monitoring System Contour Next Blood Glucose Meter Contour Next Control Solution Diastix Keto-Diastix Contour Next Blood Glucose Test Strips 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 Blood Glucose Test Strips 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 Blood Glucose Meter Contour Next Control Solutions Contour Next EZ Blood Glucose Meter Contour Next USB Blood Glucose Monitoring System Contour Next Blood Glucose Monitoring System Contour Next EZ 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 Monitoring System Contour Next Blood Glucose Test Strips Contour Next ONE Blood Glucose Meter Contour Next Blood Glucose Meter Contour Next Link Blood Glucose Meter Contour Next Link Blood Glucose Monitoring System Contour Next Blood Glucose Monitoring System Contour Next Blood Glucose Test Strips Contour Next Control Solutions Contour Control Solution Ketostix, Keto-Diastix Contour Next EZ Blood Glucose Meter Contour Next Control Solution Contour Next Blood Glucose Test Strips CONTOUR NEXT LINK 2.4 CONTOUR PLUS LINK 2.4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2016-01-21
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Unknown	Class 3	N/A	2017-12-14
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-11-22
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-11-22
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-01-20
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-01-20
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-11-18
OZO	Automated Insulin Dosing , Threshold Suspend	Unknown	Class 3	N/A	2020-04-03
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2020-04-03
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-03-11
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2024-05-13
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2022-01-31
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-11-15
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2017-01-20
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2017-01-20
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2018-10-24
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-10-24
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2018-10-24
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2016-01-21
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-01-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-01-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-01-21
OZP	Automated Insulin Dosing Device System, Single Hormonal Control	Unknown	Class 3	N/A	2020-04-03

Official Correspondent

No official correspondent registered.

US Agent Details

SANGRAM YADAV Email: Sangram.Yadav@ascensia.com Phone: (862) 2252536

Related Public Records

Same Entity

Ascensia Diabetes Care Holdings AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038419886	Ascensia Diabetes Care Poland Sp. z o.o.	Warszawa Mazowieckie, PL
3011121740	Ascensia Diabetes Care US Inc.	Parsippany, NJ, US
1810909	Ascensia Diabetes Care US Inc.	Valhalla, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973662	Boehringer Mannheim Corp.	ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS	1997-12-15
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

Similar Registrations

Registration Number	Establishment Name	Location
3014353121	VIDAN DIAGNOSTICS, LLC	San Antonio, TX, US
1810909	Ascensia Diabetes Care US Inc.	Valhalla, NY, US
2954323	ABBOTT DIABETES CARE INC.	ALAMEDA, CA, US
3003741676	ANDON HEALTH CO., LTD	TIANJIN, CN
3004193489	NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS	Billerica, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012118659. Last updated year: 2026. Please use registration number 3012118659 when referencing this establishment in official correspondence.