240165
IV
current
Occluders, Vascular, Intravascular Embolization, Particulate封堵器、血管、血管内栓塞、微粒
This profile provides complete Hong Kong MDACS registration information for Occluders, Vascular, Intravascular Embolization, Particulate. 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: Occluders, Vascular, Intravascular Embolization, Particulate
產品資訊： 封堵器、血管、血管内栓塞、微粒
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20412
Product Code Detail
20412 Occluders, Vascular, Intravascular Embolization, Particulate
State
current
Status
N/A
Manufacturer (製造商)
ENGAIN CO.,Ltd
ENGAIN CO.,Ltd
South Korea
韩国
B153, B162, B163, B173, B174 and B175, The First Tower, 10, Dongtan-daero 21-gil, Hwaseong-si, Gyeonggi-do, 18471, Republic of Korea
B153、B162、B163、B173、B174 和 B175, The First Tower, 10, Dongtan-daero 21-gil, Hwaseong-si, Gyeonggi-do, 18471, Republic of Korea
Authorised Representative (AR)
21074668
Regulatory Timeline
Registration Date
May 08, 2024
Expiry Date
May 07, 2029
Product Models
EGgel 150-350µm (1216101), EGgel 350-560µm (1216102), EGgel 560-710µm (1216103), EGgel 710-1000µm (1216104), EGgel 1000-1400µm (1216105), EGgel 1400-2000µm (1216106), EGgel S PLUS 50-150µm (1317100), EGgel S PLUS 150-350µm (1317101), EGgel S PLUS 350-560µm (1317102), EGgel S PLUS 560-710µm (1317103), EGgel S PLUS 710-1000µm (1317104), EGgel S PLUS 1000-1400µm (1317105), EGgel S PLUS 1400-2000µm (1317106), EGgel S PLUS 2000-4000µm (1317107), EGgel S PLUS MAX (1317108)
EGgel 150-350μm (1216101), EGgel 350-560μm (1216102), EGgel 560-710μm (1216103), EGgel 710-1000μm (1216104), EGgel 1000-1400μm (1216105), EGgel 1400-2000μm (1216106), EGgel S PLUS 50-10-1000μm 50μm(1317100),EGgel S PLUS 150-350μm(1317101),EGgel S PLUS 350-560μm(1317102),EGgel S PLUS 560-710μm(1317103),EGgel S PLUS 710-1000μm(1317104),EGgel S PLUS 1000-1400μm(1317105), EGgel S PLUS 1400-2000μm (1317106), EGgel S PLUS 2000-4000μm (1317107), EGgel S PLUS MAX (1317108)