Pure Global
170168
III
current

Radiographic/Fluoroscopic Systems, Angiography/Interventionalๆ”พๅฐ„/้€่ง†็ณป็ปŸ,่ก€็ฎก้€ ๅฝฑ/ไป‹ๅ…ฅ

This profile provides complete Hong Kong MDACS registration information for Radiographic/Fluoroscopic Systems, Angiography/Interventional. 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: Radiographic/Fluoroscopic Systems, Angiography/Interventional

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
16597
Product Code Detail
16597 Radiographic/Fluoroscopic Systems, Angiography/Interventional
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
GE Hualun Medical Systems Co. Ltd
ๅŒ—ไบฌ้€š็”จ็”ตๆฐ”ๅŽไผฆๅŒป็–—่ฎพๅค‡ๆœ‰้™ๅ…ฌๅธ
China
ไธญๅ›ฝ
No 1 Yong Chang North Road, Beijing Economic Technological Development Zone, Beijing 100176, China
ๅŒ—ไบฌ็ปๆตŽๆŠ€ๆœฏๅผ€ๅ‘ๅŒบๆฐธๆ˜ŒๅŒ—่ทฏ1ๅท, ๅŒ—ไบฌ100176, ไธญๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
July 13, 2022
Expiry Date
July 13, 2027
Product Models
Optima IGS 330
ๅฅฅๆ™ฎ็Ž› IGS 330