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Device Explorer · FDA GUDID · GMDN 47373

Cochlear implant system electrode array assembly

The implantable portion of a cochlear implant system [cochlear implant (CI)] that typically consists of an electrically-powered electrode array surgically implanted in one cochlea, and a receiver-stimulator implanted in the skull near the ear and connected to

US‑registered devices87in commercial distribution
Companies3labelers on GUDID
Single‑use90%of device records
Sterile95%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Med-El Elektromedizinische Geräte Gesellschaft M.B.H.6069%
Cochlear Limited2023%
Advanced Bionics, Llc78%

Top labelers

CompanyDevicesShare
Med-El Elektromedizinische Geräte Gesellschaft M.B.H.6069%
Cochlear Limited2023%
Advanced Bionics, Llc78%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HiRes™ Ultra CI HiFocus™ MS ElectrodeHiRes™ Ultra CI HiFocus™ SlimJ ElectrodeHiRes™ Ultra 3D CI HiFocus™ SlimJ ElectrodeHiRes™ Ultra 3D CI HiFocus™ MS ElectrodeCochlear® Nucleus® Nexa™ cochlear implantCochlear® Nucleus® Nexa™ cochlear implant with SCochlear® Nucleus® Nexa™ cochlear implant with SCochlear® Nucleus® Nexa™ cochlear implant with SCochlear® Nucleus® CI624 cochlear implant with SCochlear® Nucleus® CI612 cochlear ImplantCochlear® Nucleus® CI632 cochlear Implant with SCochlear® Nucleus® CI622 cochlear Implant with SCochlear® Nucleus® CI532 cochlear Implant with SCochlear® Nucleus® CI522 cochlear Implant with SNucleusCochlear® Nucleus® CI512 cochlear Implant

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MCMImplant, Cochlear82
MCMIMPLANT, COCHLEAR26
PGQCochlear Implant With Combined Electrical Stimulation And Ac23
MCMImplant, cochlear13
PGQHybrid cochlear implant1

GMDN & GCC registration

  • GMDN code 47373 · implantable
  • Single‑use 90% · sterile 95% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many cochlear implant system electrode array assembly products are registered in the US?

87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cochlear implant system electrode array assembly", from 3 companies. The largest labeler is Med-El Elektromedizinische Geräte Gesellschaft M.B.H. with 69% of records.

Which FDA product codes apply?

MCM (Implant, Cochlear), MCM (IMPLANT, COCHLEAR), PGQ (Cochlear Implant With Combined Electrical Stimulation And Ac), MCM (Implant, cochlear)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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