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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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No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA smart y
In Commercial Distribution

  • 06975136230062 ()


  • Intraoral optical scanning system
No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA smart p
In Commercial Distribution

  • 06975136230055 ()


  • Intraoral optical scanning system
No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA P3
In Commercial Distribution

  • 06975136230031 ()


  • Intraoral optical scanning system
No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA P2 Plus
In Commercial Distribution

  • 06975136230024 ()


  • Intraoral optical scanning system
No Description
Ziyang Freqty Medical Equipment Co., Ltd.
PANDA P2
In Commercial Distribution

  • 06975136230017 ()


  • Intraoral optical scanning system
No Description
Changzhou Sifary Medical Technology Co., Ltd.
Helios 600
In Commercial Distribution

  • 06975132957802 ()


  • Intraoral optical scanning system
The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS02000W
In Commercial Distribution

  • 07290016923391 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS02000
In Commercial Distribution

  • 07290016923384 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS07000WR
Not in Commercial Distribution

  • 07290016923353 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS07000W
In Commercial Distribution

  • 07290016923346 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram


  • Infrared spectrometry breath analyser IVD
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