180122
III
current
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This profile provides complete Hong Kong MDACS registration information for Radiographic/Fluoroscopic Units, Mobile. 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 Units, Mobile
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
11758
Product Code Detail
11758 Radiographic/Fluoroscopic Units, Mobile
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
GE Hualun Medical Systems Co. Ltd
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ฌๅธ
No.1 Yong Chang North Road, Beijing Economic Technological Development Zone, BEIJING 100176, CHINA
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Authorised Representative (AR)
Regulatory Timeline
Registration Date
March 03, 2023
Expiry Date
May 12, 2028
Product Models
OEC Elite MiniView (S10000AA, S10000DH, S10000EA, S10000DM, S10000AD, S10000AE, S10000AS, S10000AC, S10000DF, S10000DE, S20002HC)
OEC Elite MiniView (S10000AA, S10000DH, S10000EA, S10000DM, S10000AD, S10000AE, S10000AS, S10000AC, S10000DF, S10000DE, S20002HC)