FRESENIUS MEDICAL CARE NORTH AMERICA

127 devices 127 registrations
✕ UK (MHRA) ✕ EU (EUDAMED) ✕ AU (TGA)
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Devices

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Showing 1–20 of 127 devices

Device Name US UK CA AU EU
2008K@HOME HEMODIALYSIS MACHINE Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
2008K@HOME - REFURBISHED Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
2008T HEMODIALYSIS SYSTEM CDX Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
2008T HEMODIALYSIS SYSTEM CDX - REFURBISHED Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
90/2 PERITONEAL DIALYSIS CYCLER SET Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
AquaA Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
ARTERIAL LINE - HEMODIALYSIS BLOOD TUBING SET Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
BIBAG INSTALLATION KIT Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
BLOOD TEMPERATURE MONITOR Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
BLOOD VOLUME MONITOR Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
CAPD SAFE-LOCK CATHETER EXTENSION SET Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
CAPD SAFE-LOCK CATHETER EXTENSION SET (WITH ROLLER CLAMP) Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
C.A.P.D. SAFE-LOCK DISPOSABLE FREEDOM SET Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
CAPD SAFE-LOCK TRANSFER SET Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
COMBI SET - HEMODIALYSIS BLOOD TUBING SET Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
CRIT-LINE (CLIC) BLOOD CHAMBER Not registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
CRIT-LINE CLIP (CLIC) Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
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