International Medical Devices Database

9 devices in the database

Cybersecurity updates in Accu-Chek Inform II system,

Model / Serial
Accu-Chek Inform II system CoaguChek Pro II system CoaguChek XS Plus system CoaguChek XS Pro system cobas h 232 POC system cobas h 232 POC system (scanner version)
Product Description
Clinical chemistry substrate IVDs

Accu-Chek FlexLink Plus, Infusion administration set

Model / Serial
GWX 001 up to GWX 206 GWY 001 up to GWY 034
Product Description
Infusion administration set, insulin

CoaguChek (XS PT, XS PT PST, and PT) strips

Model / Serial
- Please check attachment for codes - ........................................................ NCMDR Update Codes: CoaguChek XS PT Test PST: 07671679xxx, 07671687xxx, 07762798xxx CoaguChek XS PT Test: 04625374xxx, 04625358xxx, 07797826xxx, 04625315xxx CoaguChek PT Test : 06688721xxx CoaguChek XS PT Test PST from #272167xx (S_303) up to #334498xx (S_343) CoaguChek XS PT Test from #272167xx (S_303) up to #334498xx (S_343) CoaguChek PT Test from #272170xx (S_054) up to #353606xx (S_061)
Product Classification
Hematology and Pathology Devices
Product Description
CoaguChek strips

cobas c 501, 502 module

Model / Serial
Affected Instrument Part: USM cover 3 GMMI / Part No: GMMI 05400937001 cobas c 501 module (GMMI 04745914001) cobas c 502 module (GMMI 05964067001)
Product Description
IVD

cobas® MPX and DPX Test, CE-IVD

Model / Serial
GMMI / Part No: 1)cobas® MPX, for use on the cobas® 6800/8800 Systems, CE-IVD 96 Tests: 06997708190 (Device Identifier: 00875197004618) 480 Tests: 06997716190 (Device Identifier: 00875197004625) 2)cobas® DPX, for use on the cobas® 6800/8800 system, CE-IVD 96 Tests: 07001088190 (Device Identifier: 00875197004984)
Product Description
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus

4 more

10 manufacturers with a similar name

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Roche Diagnostics Corporation

Manufacturer Parent Company (2017)
Roche Holding AG
Source
PMDAJ

Roche Diagnostics Corporation

Manufacturer Address
Roche Diagnostics Corporation, 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Road, Indianapolis IN 46250-0457
Source
USFDA

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
Source
USFDA

5 more

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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