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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Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
ORGENTEC Diagnostika GmbH
ORG515S
Not in Commercial Distribution

  • 04260157080140 ()
ORG515S

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Cardiolipin IgG/IgM is an ELISA test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
ORGENTEC Diagnostika GmbH
ORG515
Not in Commercial Distribution

  • 04260157080126 ()
ORG515

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
ORGENTEC Diagnostika GmbH
ORG518
Not in Commercial Distribution

  • 04260157080171 ()
ORG518

  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex
Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only.
ORGENTEC Diagnostika GmbH
ORG515A
Not in Commercial Distribution

  • 04260157080133 ()
ORG515A

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
No Description
CardioTek B.V.
03UBC02
In Commercial Distribution

  • 04260441450482 ()


  • Cardiac electrophysiology analysis system
Accessory box for Tymp probe Content: 1. Transparent Lurex Box 11 compartments. AN100336 2. Probe Tip 'Adult' for Children & Adults. AN100013 3. Probe Tip 'Small' for Babies. AN100014-W 4. Test cavity for EP-DP and EP-TE with Ear Probe Tip A. AN100129 5. Ear tip ET-03 5 mm. AN100063 6. Ear tip Lamella 6-10mm, blue. AN100064 7. Ear Tip, Lamella 8-11mm. AN100144 8. Ear tip ET-11 Lamella 12-16mm. AN100125 9. EarTip Soft ET-16 10mm. AN100838 10. Ear tip Soft ET-17 14 mm. AN100839 11. EarTip ET-20 14mm mushroom. AN100576 12. EarTip ET-21 18mm mushroom. AN100577 13. Cleaning tool. AN100151
PATH medical GmbH
100587-AD
In Commercial Distribution

  • 04260223142826 ()


  • Evoked-potential audiometer
Content: 1. Earplugs 5-8 mm PM105 2. Earplugs 6 mm PM006 3. Earplugs 7 mm PM007 4. Earplugs 8 mm PM008 5. Earplugs 9 mm PM009 6. Earplugs 10 mm PM010 7. Earplugs 16 mm PM016 8. Earplugs 11-15 mm PM111 9. Earplugs 18,5 mm PM018 10. Earplugs 7-11 mm PM107 11. Earplugs 11 mm PM011 12. Earplugs 12 mm PM012 13. Earplugs 13 mm PM013 14. Earplugs 14 mm PM014 PATH MEDICAL is not manufacturer or Labeler of this product. The legal manufacturer confirmed to submit his UDI once stablished.
PATH medical GmbH
100734
Not in Commercial Distribution

  • 04260223141775 ()


  • Evoked-potential audiometer
No Description
IT-V Medizintechnik GmbH
P10107-589
In Commercial Distribution

  • 09120074395893 ()


  • Radiological whole-body positioner
No Description
GA Health Company Limited
EN10922B
In Commercial Distribution

  • 14897106954145 ()
  • 04897106954148 ()
  • 24897106954142 ()


  • Endoscopic insufflation tubing set, single-use
No Description
GA Health Company Limited
EN10902B
In Commercial Distribution

  • 14897106954114 ()
  • 04897106954117 ()
  • 24897106954111 ()


  • Endoscopic insufflation tubing set, single-use
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