Manufacturer's Devices - Cochlear Ltd

Address:




1 University Avenue Macquarie University



Sydney

NSW 2109

Australia


Authorised Representative/ UK Responsible Person
Name: Cochlear Europe Ltd
Address:

6 Dashwood Lang Road Bourne Business Park



Addlestone

Surrey KT15 2HJ

England United Kingdom




Code/Term Type
Assistive tool fixation deviceAssistive tool fixation device
Cochlear implant system external kitCochlear implant system external kit
Earmould custom-madeEarmould custom-made
ENT surgical procedure kit non-medicated reusableENT surgical procedure kit non-medicated reusable
Surgical implant template reusableSurgical implant template reusable
Auditory brainstem implant system electrode array assemblyAuditory brainstem implant system electrode array assembly
Cochlear implant system electrode array assemblyCochlear implant system electrode array assembly
Cochlear implant/auditory brainstem implant coil cableCochlear implant/auditory brainstem implant coil cable
Cochlear electrode array introducer reusableCochlear electrode array introducer reusable
Cochlear implant implantable magnetCochlear implant implantable magnet
Cochlear implant/auditory brainstem implant sound processor speakerCochlear implant/auditory brainstem implant sound processor speaker
Surgical implant handling forcepsSurgical implant handling forceps
Cochlear implant system waterproof kitCochlear implant system waterproof kit Conformity Assessment Certificate Expired
Cochlear implant/auditory brainstem implant coil cover/spacerCochlear implant/auditory brainstem implant coil cover/spacer Conformity Assessment Certificate Expired
Cochlear implant/auditory brainstem implant sound processor off-ear holderCochlear implant/auditory brainstem implant sound processor off-ear holder Conformity Assessment Certificate Expired
Cochlear implant/auditory brainstem implant coil cover/spacerCochlear implant/auditory brainstem implant coil cover/spacerClass I
Cochlear implant dummy magnetCochlear implant dummy magnet Conformity Assessment Certificate Expired
Cochlear implant systemCochlear implant system Conformity Assessment Certificate Expired
Facility magnetic field shielding materialFacility magnetic field shielding material Conformity Assessment Certificate Expired
General-purpose medical fibre paddingGeneral-purpose medical fibre padding Conformity Assessment Certificate Expired
Cochlear electrode array introducer single-useCochlear electrode array introducer single-use Conformity Assessment Certificate Expired
Surgical implant template single-useSurgical implant template single-use Conformity Assessment Certificate Expired
Cochlear implant/auditory brainstem implant peripheral connectorCochlear implant/auditory brainstem implant peripheral connector Conformity Assessment Certificate Expired
Hearing aid/implant system programming interface unitHearing aid/implant system programming interface unitClass I
Cochlear implant/auditory brainstem implant sound processor off-ear holderCochlear implant/auditory brainstem implant sound processor off-ear holderClass I
Hearing aid/implant system remote controlHearing aid/implant system remote controlClass I
Cochlear implant/auditory brainstem implant peripheral connectorCochlear implant/auditory brainstem implant peripheral connectorClass I
Earmould preformedEarmould preformedClass I
Audiometric/hearing device softwareAudiometric/hearing device softwareClass III
Cochlear implant dummy magnetCochlear implant dummy magnetClass IIb
Cochlear implant implantable magnetCochlear implant implantable magnetClass III
Noninvasive device battery chargerNoninvasive device battery chargerClass I
Secondary batterySecondary batteryClass I
Cochlear implant/auditory brainstem implant sound processorCochlear implant/auditory brainstem implant sound processorClass III
Cochlear implant/auditory brainstem implant coilCochlear implant/auditory brainstem implant coilClass III
Cochlear implant system waterproof kitCochlear implant system waterproof kitClass I
Cochlear implant/auditory brainstem implant batteryCochlear implant/auditory brainstem implant batteryClass I
Earphone insertEarphone insertClass IIa
Cochlear implant/auditory brainstem implant sound processor earhookCochlear implant/auditory brainstem implant sound processor earhookClass I
Hearing implant system external magnetHearing implant system external magnetClass I
Cochlear electrode array depth gauge single-useCochlear electrode array depth gauge single-useClass IIa
Cochlear electrode array depth gauge single-useCochlear electrode array depth gauge single-useClass IIa
Earmould preformedEarmould preformedClass IIa
Bone-conduction hearing implant system vibrator assemblyBone-conduction hearing implant system vibrator assemblyClass III