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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
Biobase Biodustry(Shandong)Co., Ltd.
BIOBASE1000
In Commercial Distribution

  • 06971674861256 ()


  • Microplate reader IVD, automated/semi-automated
The manual refractometer is composed of a lens and a removable eye chart. The testee is required to move the position of the eye chart after resetting to make the visual target become clearer from blur. Once the clearest position of the visual target is determined, the testee’s estimated refractive error can be read from the display screen of the instrument.
Shenzhen CERTAINN Technology Co., Ltd.
iRef
In Commercial Distribution

  • 06972039971542 ()


  • Hand-held subjective ophthalmic refractometer
Meditherm Iris Digital Thermal Camera
Meditherm Incorporated
IRIS 640
In Commercial Distribution

  • B783706400170601151 ()
1706400

  • Infrared thermography system
No Description
Giles Scientific, Inc.
V3
In Commercial Distribution

  • 00863504000217 ()
BV3

  • Antimicrobial susceptibility/resistance testing interpretive software IVD
  • Colony counter IVD, automated/semi-automated
No Description
Shenzhen YHLO Biotech Co., Ltd.
UNION-C
In Commercial Distribution

  • 06925912711117 ()
U6103

  • Enzyme immunoassay (EIA) analyser IVD
The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data.
Wallac Oy
5002-0540
In Commercial Distribution

  • 06438147352401 ()
5002-0540

  • Clinical laboratory information system
Specimen Gate® Screening Center™ is intended to be used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Wallac Oy
5002-0500
In Commercial Distribution

  • 06438147320905 ()
5002-0500

  • Clinical laboratory information system
Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories.
Wallac Oy
5002-0180
In Commercial Distribution

  • 06438147153312 ()
5002-0180

  • Clinical laboratory information system
Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system.
Wallac Oy
5002-0130
In Commercial Distribution

  • 06438147153275 ()
5002-0130

  • Clinical laboratory information system
No Description
Canary Medical USA LLC
43-5570-003-15
In Commercial Distribution

  • 00860003118382 ()


  • Patient health record information system
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