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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Alinity - 00380740216085

Alere NT-proBNP for Alinity I Assay File
Abbott GmbH
04S793A
In Commercial Distribution

  • 00380740216085 ()
04S793A

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740215033

ARCHITECT cSystems Assay Disk Conventional Units version 22.0
ABBOTT LABORATORIES
08G9825
In Commercial Distribution

  • 00380740215033 ()
08G9825

  • Laboratory instrument/analyser application software IVD

EUROPicture - 04049016068815

No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0011-0101
In Commercial Distribution

  • 04049016068815 ()


  • Laboratory instrument/analyser application software IVD

EUROLineScan - 04049016068785

No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0006-0101
In Commercial Distribution

  • 04049016068785 ()


  • Laboratory instrument/analyser application software IVD

EUROLabOffice 4.0 - 04049016135210

No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0250-0101-7
In Commercial Distribution

  • 04049016135210 ()


  • Laboratory instrument/analyser application software IVD

EKF Link - 04048534002011

EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes. EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link. EKF Link facilitates the setting of configurable options of connected analyzers.
EKF-diagnostic GmbH
0760-0101
In Commercial Distribution

  • 04048534002011 ()
0760-0101

  • Laboratory instrument/analyser application software IVD

HemoCue® 801 Connect - 07311091391681

HemoCue® 801 Connect
Hemocue AB
139168
Not in Commercial Distribution

  • 07311091391681 ()
139168

  • Laboratory instrument/analyser application software IVD

Navina™ Smart App for Android - 07333387030395

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
In Commercial Distribution

75751

  • Rectal irrigation system application software

Navina™ Smart App for iOS - 07333387030388

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software

SecurView DX Manager - 15420045507388

The SecurView® DX diagnostic workstation Manager provides central database access and performs the image preparation for all connected SecurView DX Client workstations.
Hologic, Inc.
SVDX Manager
In Commercial Distribution

  • 15420045507388 ()
SVDX-00600-HIRES

  • Laboratory instrument/analyser application software IVD
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