240403
II
current
Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic, Biometryๆซๆ็ณป็ปใๆฟๅ ใๅ ๅญฆ็ธๅนฒๆญๅฑๆซๆใ็ผ็งใ็็ฉ็ป่ฎกๅญฆ
This profile provides complete Hong Kong MDACS registration information for Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic, Biometry. 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: Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic, Biometry
็ขๅ่ณ่จ๏ผ ๆซๆ็ณป็ปใๆฟๅ ใๅ ๅญฆ็ธๅนฒๆญๅฑๆซๆใ็ผ็งใ็็ฉ็ป่ฎกๅญฆ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
23549
Product Code Detail
23549 Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic, Biometry
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
NIDEK CO., LTD.
Nidek Co.,Ltd.
Japan
ๆฅๆฌ
34-14 Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan
34-14 ๅๆปจ, ๅนฟ็ณ็บ, ่ฒ้ก, ็ฑ็ฅๅฟ 443-0038, ๆฅๆฌ
Authorised Representative (AR)
Skyview Optical Company Limited
่งไฝณๅ
ๅญฆๆ้ๅ
ฌๅธ
29590077
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
Optical Biometer (AL-Scan)
ๅ
ๅญฆ็็ฉ่ฎก (AL-Scan)