Manufacturer's Devices - Integra Neurosciences Implants (France) SAS_Sophia Antipolis

Address:




2905 Route des Dolines



Sophia Antipolis

06921

France


Authorised Representative/ UK Responsible Person
Name: Integra Neurosciences Limited
Address:

Kingsgate House Newbury Road



Andover

Hampshire SP10 4DU

England United Kingdom




Code/Term Type
Cranial port/reservoirCranial port/reservoirClass III
Intracerebral infusion/drainage catheter long-termIntracerebral infusion/drainage catheter long-termClass III
Lumboperitoneal shuntLumboperitoneal shuntClass III
Lumboperitoneal shunt spinal catheterLumboperitoneal shunt spinal catheterClass III
Cortical electrodeCortical electrodeClass III
Depth electrodeDepth electrodeClass III
Spinal needle single-useSpinal needle single-useClass III
Neural-tissue balloon catheterNeural-tissue balloon catheterClass III
Cerebrospinal fluid shunt connectorCerebrospinal fluid shunt connectorClass III
Intracranial catheter holderIntracranial catheter holderClass III
Ventriculo-peritoneal/atrial shuntVentriculo-peritoneal/atrial shuntClass III
Peritoneal/atrial cerebrospinal fluid catheterPeritoneal/atrial cerebrospinal fluid catheterClass III
Intracerebral infusion/drainage catheter short-termIntracerebral infusion/drainage catheter short-termClass III
Lumbar cerebrospinal fluid drainage catheterization kitLumbar cerebrospinal fluid drainage catheterization kitClass III
Ventricular cerebrospinal fluid drainage catheterization kitVentricular cerebrospinal fluid drainage catheterization kitClass III
Subcutaneous tunneller single-useSubcutaneous tunneller single-useClass IIb
General-purpose patient temperature probe single-useGeneral-purpose patient temperature probe single-useClass IIa
Subcutaneous tunneller reusableSubcutaneous tunneller reusableClass IIa
Luer/Luer linear connector single-useLuer/Luer linear connector single-useClass I
Cerebrospinal fluid external drainage kitCerebrospinal fluid external drainage kitClass I
Sensor holder single-useSensor holder single-useClass I
Neurosurgical procedure kit non-medicated single-useNeurosurgical procedure kit non-medicated single-use Conformity Assessment Certificate ExpiredClass I
Intracerebral sensor catheter short-termIntracerebral sensor catheter short-term Conformity Assessment Certificate ExpiredClass III
Intracerebral sensor catheter short-termCerebrospinal fluid external drainage kit Conformity Assessment Certificate ExpiredClass III
Intracerebral sensor catheter short-termCerebrospinal fluid external drainage kit Conformity Assessment Certificate ExpiredClass III