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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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Blood Glucose Monitoring System
FondCircle Inc.
FBG-M2
In Commercial Distribution

  • 00850070979047 ()


  • Glucose monitoring system IVD, home-use
PREGMATE® Digital Ovulation Test
Guangzhou Decheng Biotechnology Co., LTD
1T
In Commercial Distribution

  • 00850065976648 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
PREGMATE® OVULATION TEST STRIP
Guangzhou Decheng Biotechnology Co., LTD
50T
In Commercial Distribution

  • 30850065976632 ()
  • 00850065976631 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
PREGMATE® PREGNANCY TEST STRIP
Guangzhou Decheng Biotechnology Co., LTD
50T
In Commercial Distribution

  • 30850065976625 ()
  • 00850065976624 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
The Dario USB-C Blood Glucose Monitoring System Welcome Kit is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario USB-C meter is connected to a SMD through USB-C connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.
LABSTYLE INNOVATION LTD
1264-05
In Commercial Distribution

  • 00850065006741 ()


  • Glucose monitoring system IVD, home-use
The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario USB-C meter is connected to a SMD through USB-C connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.
LABSTYLE INNOVATION LTD
1152-05
In Commercial Distribution

  • 00850065006390 ()


  • Glucose monitoring system IVD, home-use
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.
LABSTYLE INNOVATION LTD
1015-05
Not in Commercial Distribution

  • 00850065006161 ()


  • Glucose monitoring system IVD, home-use
The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario LC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform.
LABSTYLE INNOVATION LTD
1138-05
In Commercial Distribution

  • 00850065006154 ()


  • Glucose monitoring system IVD, home-use
Amazewell™ Semi-Quantitative Ovulation Rapid Test Strip, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
AOSS-SQ-25B
In Commercial Distribution

  • 30850054867491 ()
  • 00850054867490 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
Amazewell™ Ovulation Rapid Test Strip, 50T/Box
Guangzhou Decheng Biotechnology Co., LTD
AOSS-50B
In Commercial Distribution

  • 30850054867484 ()
  • 00850054867483 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing
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