Pure Global
240379
II
current

Scanning Systems, Optical Coherence Tomography, Ophthalmicๆ‰ซๆ็ณป็ปŸใ€ๅ…‰ๅญฆ็›ธๅนฒๆ–ญๅฑ‚ๆ‰ซๆใ€็œผ็ง‘

This profile provides complete Hong Kong MDACS registration information for Scanning Systems, Optical Coherence Tomography, Ophthalmic. 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.

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
N/A
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Manufacturer (่ฃฝ้€ ๅ•†)
NIDEK CO., LTD.
Nidek Co.,Ltd.
Japan
ๆ—ฅๆœฌ
34-14 Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan
34-14 ๅ‰ๆปจ, ๅนฟ็Ÿณ็”บ, ่’ฒ้ƒก, ็ˆฑ็ŸฅๅŽฟ 443-0038, ๆ—ฅๆœฌ
Authorised Representative (AR)
Skyview Optical Company Limited
่ง†ไฝณๅ…‰ๅญฆๆœ‰้™ๅ…ฌๅธ
29590077
Regulatory Timeline
Registration Date
September 11, 2024
Expiry Date
September 10, 2029
Product Models
Optical Coherence Tomography (RS-330)
ๅ…‰ๅญฆ็›ธๅนฒๆ–ญๅฑ‚ๆ‰ซๆ (RS-330)