Ascensia Diabetes Care Poland Sp. z o.o.

FDA Device Registration & Listing · Warszawa Mazowieckie, PL · Registration 3038419886

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038419886
FEI Number
3038419886
Entity Name
Ascensia Diabetes Care Poland Sp. z o.o.
City/State/Country
Warszawa Mazowieckie, PL
Establishment Address
Aleje Jerozolimskie 142B, Warszawa, Warszawa Mazowieckie 02-305, PL
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
N
Expiration Date (Year)
2026
510(k) Number
K130265
PMA Number
N/A

All Registered Proprietary Names

Contour Next Link 2.4 Wireless Blood Glucose Monitoring System Contour Next Blood Glucose Test Strips Contour Next Link 2.4 Wireless Blood Glucose Meter CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System CONTOUR® NEXT GEN Blood Glucose Monitoring System CONTOUR NEXT LINK 2.4 CONTOUR PLUS LINK 2.4 Glucofacts Deluxe Diabetes Management Software MICROLET®NEXT Lancets Contour Next Blood Glucose Test Strips Contour Next Blood Glucose Monitoring System Contour Next Blood Glucose Meter Contour Next Control Solution Contour Next ONE Blood Glucose Monitoring System 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 Contour Next EZ Blood Glucose Meter Contour Next Control Solution Contour Next Blood Glucose Test Strips 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 Glucofacts Deluxe Diabetes Management System CONTOUR® PLUS BLUE Blood Glucose Monitoring System CONTOUR® NEXT ONE Blood Glucose Monitoring System Contour Next Link Wireless Blood Glucose Meter Contour Next Blood Glucose Test Strips Contour Next Control Solution Ketostix, Keto-Diastix Contour Contour TS Contour Next Link Wireless Blood Glucose Meter Contour Next Blood Glucose Test Strips Contour® next GEN Blood Glucose Monitoring System MICROLET NEXT lancing device, MICROLET Lancet Contour Next EZ Blood Glucose Monitoring System Contour Next EZ Blood Glucose Meter Contour Next Blood Glucose Test Strips

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OZO Automated Insulin Dosing , Threshold Suspend Unknown Class 3 N/A 2016-08-11
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2025-03-12
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2023-04-12
OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown Class 3 N/A 2020-04-03
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2016-01-21
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2026-03-11
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
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
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
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
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2019-11-15
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 2024-05-13
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2021-09-13
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2021-09-13
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
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
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 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 2022-01-31
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2022-11-18
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

Official Correspondent

No official correspondent registered.

US Agent Details

Brian Truchan Business: ASCENSIA DIABETES CARE HOLDINGS AG Email: brian.truchan@ascensia.com Phone: (914) 3563140

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
3012118659 ASCENSIA DIABETES CARE HOLDINGS AG Basel Basel-Stadt, CH
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
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
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2025 Medtronic MiniMed, Inc. 3
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
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

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3013756811 Tandem Diabetes Care, INC. San Diego, CA, US
1810909 Ascensia Diabetes Care US Inc. Valhalla, NY, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038419886. Last updated year: 2026. Please use registration number 3038419886 when referencing this establishment in official correspondence.
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