Manufacturer's Devices - FUJIFILM Corporation

Address:




26-30 Nishiazabu 2-chome

Minato-ku

Tokyo

106-8620

Japan


Authorised Representative/ UK Responsible Person
Name: Fujifilm UK Limited
Address:

Fujifilm House Whitbread Way



Bedford

MK42 0ZE

England United Kingdom




Code/Term Type
Digital imaging storage phosphor screenDigital imaging storage phosphor screenClass IIa
Mobile basic diagnostic x-ray system digitalMobile basic diagnostic x-ray system digital
Stationary basic diagnostic x-ray system digitalStationary basic diagnostic x-ray system digital
C-reactive protein (CRP) IVD reagentC-reactive protein (CRP) IVD reagentIVD General
Densitometry analyser IVDDensitometry analyser IVDIVD General
Nephelometry/turbidimetry analyser IVD manualNephelometry/turbidimetry analyser IVD manualClass A
Endoscopic video image processing unitEndoscopic video image processing unitClass I
Endoscopic bite block basic single-useEndoscopic bite block basic single-useClass I
Surgical instrument/endoscope cleaning utensil reusableSurgical instrument/endoscope cleaning utensil reusableClass I
Endoscopic light source unit battery-poweredEndoscopic light source unit battery-poweredClass I
Foot-switch electricalFoot-switch electricalClass I
Invasive medical device leak tester mechanicalInvasive medical device leak tester mechanicalClass I
Multiple clinical chemistry analyser IVD laboratoryMultiple clinical chemistry analyser IVD laboratoryIVD General
Albumin IVD kit spectrophotometryAlbumin IVD kit spectrophotometryIVD General
Mycobacterium tuberculosis complex species antigen IVD kit rapid ICT clinicalMycobacterium tuberculosis complex species antigen IVD kit rapid ICT clinicalIVD General
Multiple electrolyte IVD calibratorMultiple electrolyte IVD calibratorIVD General
Plasma filtration/collection kit IVDPlasma filtration/collection kit IVDIVD General
Pipette tip IVDPipette tip IVDIVD General
General specimen container IVD additive/mediumGeneral specimen container IVD additive/mediumIVD General
General specimen container IVD no additive/mediumGeneral specimen container IVD no additive/mediumIVD General
Influenza A/B virus antigen IVD kit rapid ICT clinicalInfluenza A/B virus antigen IVD kit rapid ICT clinicalIVD General
Multiple respiratory virus antigen IVD kit rapid ICT clinicalMultiple respiratory virus antigen IVD kit rapid ICT clinicalIVD General
Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalBeta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinicalIVD General
Surgical instrument/endoscope cleaning utensil single-useSurgical instrument/endoscope cleaning utensil single-useClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Flexible video enteroscopeFlexible video enteroscopeClass I
Flexible video enteroscopeFlexible video enteroscopeClass I
Flexible ultrasound gastroduodenoscopeFlexible ultrasound gastroduodenoscopeClass I
Flexible ultrasound bronchoscopeFlexible ultrasound bronchoscopeClass I
Catheter/overtube balloon inflator reusableCatheter/overtube balloon inflator reusableClass I
Flexible video duodenoscope reusableFlexible video duodenoscope reusableClass I
Flexible video gastroduodenoscopeFlexible video gastroduodenoscopeClass I
Surgical irrigation pumpSurgical irrigation pumpClass I
Endoscope fluid protection capEndoscope fluid protection capClass I
Endoscopic suction valve single-use sterileEndoscopic suction valve single-use sterileClass I
Endoscopic suction valve single-use sterileEndoscopic suction valve single-use sterileClass I
Endoscopic procedure air/water valve reusableEndoscopic procedure air/water valve reusableClass I
Endoscopic suction valve reusableEndoscopic suction valve reusableClass I
Endoscopic suction valve single-use non-sterileEndoscopic suction valve single-use non-sterileClass I
Endoscopic biopsy valve single-useEndoscopic biopsy valve single-useClass I
Endoscopic bite block basic reusableEndoscopic bite block basic reusableClass I
Computer/medical device keyboardComputer/medical device keyboardClass I
Endoscope flushing adaptor reusableEndoscope flushing adaptor reusableClass I
Endoscope working-channel sealEndoscope working-channel sealClass I
Procedural cold light bulbProcedural cold light bulbClass I
Computed radiography digital imaging scannerComputed radiography digital imaging scannerClass I
Urea IVD kit enzyme spectrophotometryUrea IVD kit enzyme spectrophotometryIVD General
Calcium (Ca2+) IVD kit spectrophotometryCalcium (Ca2+) IVD kit spectrophotometryIVD General
Pseudocholinesterase IVD kit enzyme spectrophotometryPseudocholinesterase IVD kit enzyme spectrophotometryIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD kit enzyme spectrophotometryCreatine kinase myocardial isoenzyme (CKMB) IVD kit enzyme spectrophotometryIVD General
Total creatine kinase (CK) IVD kit enzyme spectrophotometryTotal creatine kinase (CK) IVD kit enzyme spectrophotometryIVD General
Creatinine IVD kit enzyme spectrophotometryCreatinine IVD kit enzyme spectrophotometryIVD General
C-reactive protein (CRP) IVD kit enzyme immunoassay (EIA)C-reactive protein (CRP) IVD kit enzyme immunoassay (EIA)IVD General
Conjugated (direct) bilirubin IVD kit spectrophotometryConjugated (direct) bilirubin IVD kit spectrophotometryIVD General
Total amylase IVD kit enzyme spectrophotometryTotal amylase IVD kit enzyme spectrophotometryIVD General
Total alkaline phosphatase (ALP) IVD kit enzyme spectrophotometryTotal alkaline phosphatase (ALP) IVD kit enzyme spectrophotometryIVD General
Multiple clinical chemistry analyser IVD laboratoryMultiple clinical chemistry analyser IVD laboratoryClass A
Single-channel clinical chemistry analyser IVD point-of-careSingle-channel clinical chemistry analyser IVD point-of-careClass A
Gamma-glutamyltransferase (GGT) IVD kit enzyme spectrophotometryGamma-glutamyltransferase (GGT) IVD kit enzyme spectrophotometryIVD General
Glucose IVD kit enzyme spectrophotometryGlucose IVD kit enzyme spectrophotometryIVD General
Triglyceride IVD kit enzyme spectrophotometryTriglyceride IVD kit enzyme spectrophotometryIVD General
Total cholesterol lipid IVD kit enzyme spectrophotometryTotal cholesterol lipid IVD kit enzyme spectrophotometryIVD General
Carbon dioxide (CO2) IVD kit spectrophotometryCarbon dioxide (CO2) IVD kit spectrophotometryIVD General
Total protein IVD kit spectrophotometryTotal protein IVD kit spectrophotometryIVD General
Uric acid IVD kit enzyme spectrophotometryUric acid IVD kit enzyme spectrophotometryIVD General
C-reactive protein (CRP) IVD calibratorC-reactive protein (CRP) IVD calibratorIVD General
Ammonia IVD controlAmmonia IVD controlIVD General
Multiple-type clinical chemistry analyte profile IVD controlMultiple-type clinical chemistry analyte profile IVD controlIVD General
Total bilirubin IVD kit spectrophotometryTotal bilirubin IVD kit spectrophotometryIVD General
Ammonia IVD kit spectrophotometryAmmonia IVD kit spectrophotometryIVD General
Multiple electrolyte IVD kit ion-selective electrode (ISE)Multiple electrolyte IVD kit ion-selective electrode (ISE)IVD General
Total aspartate aminotransferase (AST) IVD kit enzyme spectrophotometryTotal aspartate aminotransferase (AST) IVD kit enzyme spectrophotometryIVD General
High density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryHigh density lipoprotein (HDL) cholesterol IVD kit enzyme spectrophotometryIVD General
Inorganic phosphate (PO43-) IVD kit spectrophotometryInorganic phosphate (PO43-) IVD kit spectrophotometryIVD General
Alanine aminotransferase (ALT) IVD kit enzyme spectrophotometryAlanine aminotransferase (ALT) IVD kit enzyme spectrophotometryIVD General
Oxytocinase IVD kit colorimetricOxytocinase IVD kit colorimetricIVD General
Lipase IVD kit enzyme spectrophotometryLipase IVD kit enzyme spectrophotometryIVD General
Total lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometryTotal lactate dehydrogenase (LDH) IVD kit enzyme spectrophotometryIVD General
Magnesium (Mg2+) IVD kit spectrophotometryMagnesium (Mg2+) IVD kit spectrophotometryIVD General
Multiple electrolyte IVD controlMultiple electrolyte IVD controlIVD General
Diagnostic x-ray system generator portableDiagnostic x-ray system generator portableClass IIb
Stationary basic diagnostic x-ray system analogueStationary basic diagnostic x-ray system analogueClass IIb
Mobile basic diagnostic x-ray system digitalMobile basic diagnostic x-ray system digitalClass IIb
Stationary mammographic x-ray system digitalStationary mammographic x-ray system digitalClass IIb
Radiology picture archiving and communication system workstationRadiology picture archiving and communication system workstationClass IIa
Medical x-ray film screenMedical x-ray film screenClass IIa
Hand-held ultrasound imaging system body-surfaceHand-held ultrasound imaging system body-surfaceClass IIa
Diagnostic x-ray digital imaging conversion systemDiagnostic x-ray digital imaging conversion systemClass IIa
Diagnostic x-ray digital imaging system workstationDiagnostic x-ray digital imaging system workstationClass IIa
Computed radiography digital imaging scannerComputed radiography digital imaging scannerClass I
Diagnostic-imaging multiformat cameraDiagnostic-imaging multiformat cameraClass I
Diagnostic x-ray system generator portableDiagnostic x-ray system generator portableClass I
Mobile basic diagnostic x-ray system digitalMobile basic diagnostic x-ray system digitalClass I
Diagnostic-imaging photographic film self-developingDiagnostic-imaging photographic film self-developingClass I
Stationary mammographic x-ray system digitalStationary mammographic x-ray system digitalClass I
Diagnostic x-ray digital imaging conversion systemDiagnostic x-ray digital imaging conversion systemClass I
Endoscopic video image processing/light source systemEndoscopic video image processing/light source systemClass IIa
Endoscopic light source unit line-poweredEndoscopic light source unit line-poweredClass IIa
Flexible fibreoptic nasopharyngoscopeFlexible fibreoptic nasopharyngoscopeClass IIa
Flexible fibreoptic bronchoscopeFlexible fibreoptic bronchoscopeClass IIa
Flexible video duodenoscope reusableFlexible video duodenoscope reusableClass IIa
Flexible video colonoscope reusableFlexible video colonoscope reusableClass IIa
Flexible video enteroscopeFlexible video enteroscopeClass IIa
Flexible ultrasound gastroduodenoscopeFlexible ultrasound gastroduodenoscopeClass IIa
Flexible video gastroduodenoscopeFlexible video gastroduodenoscopeClass IIa
General-purpose ultrasound imaging systemGeneral-purpose ultrasound imaging systemClass IIa
Surgical ultrasound imaging transducerSurgical ultrasound imaging transducerClass IIa
Gastrointestinal endoscopic insufflatorGastrointestinal endoscopic insufflatorClass IIa
Flexible ultrasound bronchoscopeFlexible ultrasound bronchoscopeClass IIa
Flexible video nasopharyngoscopeFlexible video nasopharyngoscopeClass IIa
Gastrointestinal/biliary dilation balloon catheterGastrointestinal/biliary dilation balloon catheterClass IIa
Gastrointestinal/biliary dilation balloon catheterGastrointestinal/biliary dilation balloon catheterClass IIa
Catheter/overtube balloon inflator reusableCatheter/overtube balloon inflator reusableClass IIa
Endoscopic overtube single-useEndoscopic overtube single-useClass IIa
Endoscope tissue removal cap single-useEndoscope tissue removal cap single-useClass IIa
Endoscopic insufflation tubing set single-useEndoscopic insufflation tubing set single-useClass IIa
Ultrasound endoscope balloon Hevea-latexUltrasound endoscope balloon Hevea-latexClass IIa
Luminal device flushing tubing set reusableLuminal device flushing tubing set reusableClass IIa
Ultrasound endoscope balloon synthetic polymerUltrasound endoscope balloon synthetic polymerClass IIa
Surgical irrigation pumpSurgical irrigation pumpClass IIa
Surgical irrigation pumpSurgical irrigation pumpClass IIa
Suction/irrigation tubing reusableSuction/irrigation tubing reusableClass IIa
Flexible video upper/lower gastrointestinal endoscopeFlexible video upper/lower gastrointestinal endoscopeClass IIa
Endoscopic electrosurgical electrode monopolar single-useEndoscopic electrosurgical electrode monopolar single-useClass IIb
Endoscopic video image interpretive softwareEndoscopic video image interpretive softwareClass IIa
Diagnostic x-ray digital imaging system workstationDiagnostic x-ray digital imaging system workstationClass IIa
Endoscopic video image processing/light source systemEndoscopic video image processing/light source systemClass IIa
Diagnostic x-ray digital imaging conversion systemDiagnostic x-ray digital imaging conversion systemClass IIa
Flexible video bronchoscope reusableFlexible video bronchoscope reusableClass IIa
Flexible video bronchoscope reusableFlexible video bronchoscope reusableClass IIa
Endoscopic video image reference scale softwareEndoscopic video image reference scale softwareClass IIa
Flexible video colonoscope reusableFlexible video colonoscope reusableClass IIa
Flexible video bronchoscope reusableFlexible video bronchoscope reusableClass IIa
Flexible ultrasound gastroduodenoscopeFlexible ultrasound gastroduodenoscopeClass IIa
Luminal device flushing tubing set reusableLuminal device flushing tubing set reusableClass I
Surgical ultrasound imaging transducerSurgical ultrasound imaging transducerClass IIa
Computed radiography digital imaging scannerComputed radiography digital imaging scannerClass IIa
Computed radiography digital imaging scannerComputed radiography digital imaging scannerClass IIa