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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The BreathIDĀ® 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 BreathIDĀ® 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 BreathIDĀ® Smart System consists of the appropriate IDkit: Hpā„¢ kit and the BreathIDĀ® Smart device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS07000R
Not in Commercial Distribution

  • 07290016923278 ()

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


  • Infrared spectrometry breath analyser IVD
The BreathIDĀ® 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 BreathIDĀ® 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 BreathIDĀ® Smart System consists of the appropriate IDkit: Hpā„¢ kit and the BreathIDĀ® Smart device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS07000
In Commercial Distribution

  • 07290016923223 ()

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


  • Infrared spectrometry breath analyser IVD
The BreathIDĀ® 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 BreathIDĀ® 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 BreathIDĀ® Hp Lab System consists of the appropriate IDkit: Hpā„¢ kit, and the BreathIDĀ® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01082R
Not in Commercial Distribution

  • 07290016923162 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
  • Height: 10 Inch
  • Width: 15.7 Inch
  • Depth: 18 Inch
  • Weight: 9 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathIDĀ® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /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 BreathIDĀ® Hp 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 BreathIDĀ® Hp System consists of the appropriate IDkit:Hpā„¢ kit and the BreathIDĀ® Hp test device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01000R
Not in Commercial Distribution

  • 07290016923148 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
VS01000R

  • Infrared spectrometry breath analyser IVD
The BreathIDĀ® 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 BreathIDĀ® 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 BreathIDĀ® Hp Lab System consists of the appropriate IDkit: Hpā„¢ kit, and the BreathIDĀ® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01082
In Commercial Distribution

  • 07290016923070 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
  • Height: 10 Inch
  • Width: 15.7 Inch
  • Depth: 18 Inch
  • Weight: 9 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathIDĀ® 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 BreathIDĀ® 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 BreathIDĀ® Hp Lab System consists of the appropriate IDkit: Hpā„¢ kit, and the BreathIDĀ® Hp device, Auto Sampler and Lab Application
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01085
In Commercial Distribution

  • 07290016923063 ()

  • Height: 10 Inch
  • Width: 15.7 Inch
  • Depth: 18 Inch
  • Weight: 9 Kilogram


  • Infrared spectrometry breath analyser IVD
The BreathIDĀ® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /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 BreathIDĀ® Hp 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 BreathIDĀ® Hp System consists of the appropriate IDkit:Hpā„¢ kit and the BreathIDĀ® Hp test device.
MERIDIAN BIOSCIENCE ISRAEL LTD
VS01000
In Commercial Distribution

  • 07290016923056 ()

  • Height: 16 Inch
  • Width: 15 Inch
  • Depth: 22 Inch
  • Weight: 15 Kilogram
VS01000

  • Infrared spectrometry breath analyser IVD
No Description
Fussen Technology Co., Ltd.
S6500
In Commercial Distribution

  • 06974566270051 ()


  • Intraoral optical scanning system
No Description
Fussen Technology Co., Ltd.
S7000 Premium
In Commercial Distribution

  • 06974566270037 ()


  • Intraoral optical scanning system
No Description
Fussen Technology Co., Ltd.
S7000
In Commercial Distribution

  • 06974566270020 ()


  • Intraoral optical scanning system
No Description
Fussen Technology Co., Ltd.
S6000
In Commercial Distribution

  • 06974566270006 ()


  • Intraoral optical scanning system
The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
Elegant 3
In Commercial Distribution

  • 06970163081779 ()


  • Intraoral optical scanning system
No Description
DDS INC
COMFORT+
In Commercial Distribution

  • 18800160000006 ()


  • Intraoral optical scanning system
The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
Aoralscan 2
In Commercial Distribution

  • 06970163080024 ()


  • Intraoral optical scanning system
The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing.
Shining 3D Tech Co., Ltd.
Aoralscan 2
In Commercial Distribution

  • 06970163080017 ()


  • Intraoral optical scanning system
No Description
Wuhan Ruler Technology Co., Ltd.
JMO1
In Commercial Distribution

  • 16976986101011 ()


  • Intraoral optical scanning system
No Description
Changzhou Sifary Medical Technology Co., Ltd.
Helios 500
In Commercial Distribution

  • 06941877807962 ()


  • Intraoral optical scanning system
VivaScan Intraoral Scanner
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
740278
In Commercial Distribution

  • DIVO7402780 ()
  • DIVO7402781 ()
740278

  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
ST 200E Handpiece
In Commercial Distribution

  • 06973993440204 ()


  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
NeoScan 2000-Handpiece
In Commercial Distribution

  • 06973993440099 ()
91041

  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
AS 260 Handpiece
In Commercial Distribution

  • 06973993440051 ()
6583243

  • Intraoral optical scanning system
Iintraoral Scanner Handpiece Spare
Alliedstar Medical Equipment Co., Ltd.
Handpiece Spare
In Commercial Distribution

  • 06973993440044 ()
91021

  • Intraoral optical scanning system
Handpiece Spare
Alliedstar Medical Equipment Co., Ltd.
AS 200E
In Commercial Distribution

  • 06973993440037 ()
6583217

  • Intraoral optical scanning system
Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
ST 200E
In Commercial Distribution

  • 06973993442222 ()


  • Intraoral optical scanning system
Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
NeoScan 2000
In Commercial Distribution

  • 06973993442086 ()
91001

  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
AS 260
In Commercial Distribution

  • 06973993442048 ()
6583207

  • Intraoral optical scanning system
NeoScan 1000 Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
NeoScan 1000
In Commercial Distribution

  • 06973993442031 ()
91000

  • Intraoral optical scanning system
AS 200E – Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
AS 200E
In Commercial Distribution

  • 06973993442024 ()
6583202

  • Intraoral optical scanning system
AS 100 Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
AS 100
In Commercial Distribution

  • 06973993442017 ()
6583169

  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
ST 200E Charging Holder
In Commercial Distribution

  • 06973993441584 ()


  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
NeoScan 2000-Charging Holder
In Commercial Distribution

  • 06973993441263 ()
91042

  • Intraoral optical scanning system
Intraoral scanner holder set
Alliedstar Medical Equipment Co., Ltd.
Holder set
In Commercial Distribution

  • 06973993441096 ()
91020

  • Intraoral optical scanning system
Intraoral scanner S tip
Alliedstar Medical Equipment Co., Ltd.
TP103N
In Commercial Distribution

  • 26973993441069 ()
  • 06973993441065 ()
91013

  • Intraoral optical scanning system
Introral scanner L tip
Alliedstar Medical Equipment Co., Ltd.
TP102N
In Commercial Distribution

  • 06973993441058 ()
  • 26973993441052 ()
91012

  • Intraoral optical scanning system
AS 200E Autoclavable Tip S
Alliedstar Medical Equipment Co., Ltd.
TP203
In Commercial Distribution

  • 26973993441045 ()
  • 06973993441041 ()
6583225

  • Intraoral optical scanning system
AS 200E Autoclavable Tip L
Alliedstar Medical Equipment Co., Ltd.
TP202
In Commercial Distribution

  • 26973993441038 ()
  • 06973993441034 ()
6583226

  • Intraoral optical scanning system
Intraoral Scanner
Guangdong Launca Medical Device Technology Co., Ltd.
DL-300 Wireless
In Commercial Distribution

  • 06973747200146 ()


  • Intraoral optical scanning system
Intraoral Scanner
Guangdong Launca Medical Device Technology Co., Ltd.
DL-300P
In Commercial Distribution

  • 06973747200139 ()


  • Intraoral optical scanning system
Intraoral Scanner
Guangdong Launca Medical Device Technology Co., Ltd.
DL-300
In Commercial Distribution

  • 06973747200122 ()


  • Intraoral optical scanning system
No Description
Guangdong Launca Medical Device Technology Co., Ltd.
1
In Commercial Distribution

  • 06973747200115 ()


  • Intraoral optical scanning system
No Description
Guangdong Launca Medical Device Technology Co., Ltd.
1
In Commercial Distribution

  • 06973747200108 ()


  • Intraoral optical scanning system
No Description
Guangdong Launca Medical Device Technology Co., Ltd.
1
In Commercial Distribution

  • 06973747200092 ()


  • Intraoral optical scanning system
No Description
Guangdong Launca Medical Device Technology Co., Ltd.
1
In Commercial Distribution

  • 06973747200085 ()


  • Intraoral optical scanning system
No Description
Guangdong Launca Medical Device Technology Co., Ltd.
1
In Commercial Distribution

  • 06973747200078 ()


  • Intraoral optical scanning system
No Description
Guangdong Launca Medical Device Technology Co., Ltd.
1
In Commercial Distribution

  • 06973747200061 ()


  • Intraoral optical scanning system
Ceramill map DRS
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
754472
In Commercial Distribution

  • DIVO7544720 ()
  • DIVO7544721 ()
754472

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

  • 06975136230123 ()


  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
S300W
In Commercial Distribution

  • 06973993442529 ()
6583441

  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
S300W
In Commercial Distribution

  • 06973993442512 ()
6583440

  • Intraoral optical scanning system
No Description
Alliedstar Medical Equipment Co., Ltd.
S300W
In Commercial Distribution

  • 06973993442284 ()
6583318

  • Intraoral optical scanning system
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