230423
IV
current
Stimulators, Electrical, Auditory, Cochlearๅบๆฟๅจ, ็ต, ๅฌ่ง, ่ณ่
This profile provides complete Hong Kong MDACS registration information for Stimulators, Electrical, Auditory, Cochlear. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Stimulators, Electrical, Auditory, Cochlear
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
16035
Product Code Detail
16035 Stimulators, Electrical, Auditory, Cochlear
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Cochlear Limited
Cochlear
1 University Avenue, Macquarie University NSW 2109, AUSTRALIA
1 University Avenue, Macquarie University NSW 2109, AUSTRALIA
Authorised Representative (AR)
Cochlear (HK) Limited
็งๅฉ่ณๆ้ๅ
ฌๅธ
25305773
Regulatory Timeline
Registration Date
November 15, 2023
Expiry Date
November 15, 2028
Product Models
Cochlear Nucleus CI612 Cochlear Implant with Contour Advance electrode (P774600), Cochlear Nucleus CI622 Cochlear Implant with Slim Straight electrode (P783829), Cochlear Nucleus CI632 Cochlear Implant with Slim Modiolar electrode (P783831), Cochlear Nucleus Non-Magnetic Cassette (P782484), Cochlear Nucleus Replacement Magnet Cassette (P782485)
ไบบๅทฅ่ณ่ CI612 ไบบๅทฅ่ณ่,ๅธฆ่ฝฎๅปๆจ่ฟ็ตๆ (P774600),ไบบๅทฅ่ณ่ CI622 ไบบๅทฅ่ณ่,ๅธฆ็ป้ฟ็ด็ตๆ (P783829),ไบบๅทฅ่ณ่ CI632 ไบบๅทฅ่ณ่,ๅธฆ็ป้ฟ Modiolar ็ตๆ (P783831),ไบบๅทฅ่ณ่ๆ ธ้็ฃๆง็ (P782484),ไบบๅทฅ่ณ่ๆ ธๆฟๆข็ฃ้็ (P782485)