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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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SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N13-1
In Commercial Distribution

  • 07332940004569 ()
SC2500N13-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N14-1
In Commercial Distribution

  • 07332940004545 ()
SC2500N14-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N15-1
In Commercial Distribution

  • 07332940004538 ()
SC2500N15-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
CEPHEID
SC2500N16-1
In Commercial Distribution

  • 07332940004521 ()
SC2500N16-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Galilei G6 Lens Professional
SIS AG, Surgical Instrument Systems
G6
In Commercial Distribution

  • 07640167751242 ()
410.030.007

  • Optical low coherence reflectometry (OLCR) biometer
  • Eye anterior segment analyser
  • Corneal topography system application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Multi User License (up to 10 User) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-A2
In Commercial Distribution

  • 07290110255428 ()
HASP-SW-K-NEMS-A-02

  • Patient-administration information system application software
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis, including support for NR via USB The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-2
In Commercial Distribution

  • 07290110254971 ()
HASP-SW-K-NH301-4-02

  • Electrocardiographic long-term ambulatory recording analyser
Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment.
Philips Medical Systems Nederland B.V.
Philips Hemodynamic Application - 1
In Commercial Distribution

  • 00884838084544 ()
002010

  • Haemodynamic monitoring system application software
No Description
Avreo Inc
Version 8.8.0.21349
In Commercial Distribution

  • 00850054590121 ()


  • Radiological PACS software
  • Radiology information system
No Description
Avreo Inc
Version 8.7.0.21126
In Commercial Distribution

  • 00850054590114 ()


  • Radiological PACS software
  • Radiology information system
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