Cochlear
Impianti cocleari, impianti a conduzione ossea e apparecchi acustici.
Cochlear produce impianti cocleari, impianti a conduzione ossea e dispositivi acustici dalle sue sedi di Sydney. L'azienda fornisce sistemi sanitari, laboratori, partner OEM o clienti esportatori regolamentati nei suoi mercati primari quotati.
- Type
- brand seeking distribution
- Location
- Sydney, Australia
- Founded
- 1981
- Website
- cochlear.com
- Categories
- Forniture medicali e sanitarie, Wearable e dispositivi personali
- Markets
- Australia, Stati Uniti, Germania, Giappone
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- fda-registered (green), checked 2026-08-08 FDA
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- lei-active (green), checked 2026-08-30 GLEIF global LEI register (golden copy)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)