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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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Stationary x-ray system
Philips Healthcare (Suzhou) Co., Ltd.
712204
In Commercial Distribution

  • 00884838095199 ()


  • Stationary basic diagnostic x-ray system, digital
The CT 5300 is a Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device includes data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components.
Philips Healthcare (Suzhou) Co., Ltd.
728285
In Commercial Distribution

  • 00884838113237 ()
728285

  • Full-body CT system
OHDII FHD QL AIR05
MAQUET SAS
ARD568803969
In Commercial Distribution

  • 03700712434298 ()


  • Surgical video camera
Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the A.M.I. HAL/RAR System. The A.M.I. HAL-II Electronic System is a Doppler-based device. It is powered by a DC voltage source (rechargeable batteries or 12 V adapter). The A.M.I. HAL-II Electronic System generates electrical signals, calculates differences between the wavelength of outgoing and reflected electrical signals, and generates an acoustic Doppler signal. Together with auxiliary A.M.I. devices (A.M.I. HAL Handle, Probe and Sleeve) the A.M.I. HAL-II Electronic System serves for the detection of haemorrhoidal arteries and enables manual ligation of detected arteries, as well as mucopexy of prolapsing haemorrhoidal mucosa.
AMI Agency for Medical Innovations GmbH
AHE 203
Not in Commercial Distribution

  • EAMIAHE2030 ()

  • Weight: 3.2 Kilogram
  • Depth: 260 Millimeter
  • Height: 140 Millimeter
  • Width: 385 Millimeter
AHE 203

  • Noninvasive vascular ultrasound system
No Description
TELEFLEX INCORPORATED
IPN924894
In Commercial Distribution

  • 24026704741834 ()
  • 14026704741837 ()

  • Weight: 15.8 Pound
  • Width: 14 Inch
  • Height: 5.5 Inch
  • Length: 12 Inch
528300PS

  • General-purpose light source
No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
2001589-232
In Commercial Distribution

  • 04260671372202 ()

  • Length: 405 Millimeter
  • Width: 115 Millimeter


  • Blood pressure cuff, single-use
Gastroscope
Ambu A/S
582101000
In Commercial Distribution

  • 05707480161867 ()
  • 05707480161850 ()

  • Outer Diameter: 12 Millimeter
  • Lumen/Inner Diameter: 4.2 Millimeter
  • Length: 103 Centimeter
582101000

  • Flexible video gastroscope, single-use
NeoNavia FlexiPulse probe
NeoDynamics AB (publ)
2104
Not in Commercial Distribution

  • 27350081940076 ()
  • 17350081940079 ()
  • 37350081940073 ()

  • Needle Gauge: 14 Gauge
2104

  • End-cut biopsy gun needle
The CardioSen’C is a personal, hand-held device, enabling an individual to immediately transmit a 12-lead ECG from anywhere and anytime, to a physician's office, hospital or monitoring center. The ECG measurement can be transmitted in real time via two distinct channels. The CardioSen’C produces an ECG-modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The data can also be transmitted digitally through a cellular telephone network by use of the device’sintegrated cellular modem. Either one of these two transmissions permits the complete and reliable transfer of a 12-lead ECG immediately to a certified medical body capable of interpreting the results.
SHL TELEMEDICINE INTERNATIONAL LTD.
4.2
In Commercial Distribution

  • 07290008960250 ()

  • Weight: 300 Gram
  • Height: 4 Centimeter
  • Width: 7 Centimeter
  • Length: 13 Centimeter
  • Belt (Length) :29 cm


  • Electrocardiograph, home-use
The MARNUR Blood Pressure Monitor TMB-1583 is digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 42 cm (about 8¾˝-16½˝). It is intended for adult indoor use only.
Shenzhenshi Dingqian E-Commerce Co.,Ltd.
TMB-1583
In Commercial Distribution

  • 06971508420000 ()
  • 36971508420001 ()

  • Weight: 250 Gram
  • Height: 118 Millimeter
  • Width: 103 Millimeter
  • Length: 107 Millimeter


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
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