Occluders, Vascular, Intravascular Embolization, Particulate

封堵器、血管、血管内栓塞、微粒

ENGAIN CO.,Ltd·IV·Hong Kong MDACS·Registered May 08, 2024

Device overview

Risk class: IV
Product code: 20412
State: current
Status: N/A
Product code detail: 20412 Occluders, Vascular, Intravascular Embolization, Particulate

Manufacturer (製造商)

Name: ENGAIN CO.,Ltd
ENGAIN CO.,Ltd
Country: South Korea
韩国
Address: 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)

Name: Transmedic China Limited
Phone: 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)

About this record

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