Pure Global
170032

Procedure Kit/Trays, Implant Delivery, Stent, Vascular, Aorta Dissection

手术套件/托盘、植入物输送、支架、血管、主动脉夹层
Endologix International Holdings B.V.·IV·Hong Kong MDACS·Registered November 09, 2018
Device overview
Risk class
IV
Product code
26789
State
Expired.
Status
N/A
Product code detail
26789 Procedure Kit/Trays, Implant Delivery, Stent, Vascular, Aorta Dissection
Manufacturer (製造商)
Name
Endologix International Holdings B.V.
Endologix International Holdings B.V.
Country
Netherlands
荷兰
Address
Burgemeester Burgerslaan 40, 5245 NH Rosmalen, The Netherlands
Burgemeester Burgerslaan 40, 5245 NH Rosmalen, 荷兰
Authorised representative (AR)
Name
Synapse Therapeutics Limited
百谷医疗科技有限公司
Phone
31881638
Regulatory timeline
Registration date
November 09, 2018
Expiry date
March 10, 2022
Product models
AFX2 Bifurcated Endograft System (BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-120/I16-40, BEA22-100/I16-40, BEA22-80/I16-40, BEA22-60/I16-40, BEA22-120/I13-40, BEA22-100/I13-40, BEA22-80/I13-40, BEA22-60/I13-40, BEA22-110/I20-30, BEA22-90/I20-30, BEA22-70/I20-30, BEA22-50/I20-30, BEA22-110/I16-30, BEA22-90/I16-30, BEA22-70/I16-30, BEA22-50/I16-30, BEA22-100/I20-55, BEA22-80/I20-55, BEA22-100/I16-55, BEA22-80/I16-55, BEA25-120/I20-40, BEA25-100/I20-40, BEA25-80/I20-40, BEA25-60/I20-40, BEA25-120/I16-40, BEA25-100/I16-40, BEA25-80/I16-40, BEA25-60/I16-40, BEA25-120/I13-40, BEA25-100/I13-40, BEA25-80/I13-40, BEA25-60/I13-40, BEA25-110/I20-30, BEA25-90/I20-30, BEA25-70/I20-30, BEA25-50/I20-30, BEA25-110/I16-30, BEA25-90/I16-30, BEA25-70/I16-30, BEA25-50/I16-30, BEA25-100/I20-55, BEA25-80/I20-55, BEA25-100/I16-55, BEA25-80/I16-55, BEA28-120/I20-40, BEA28-100/I20-40, BEA28-80/I20-40, BEA28-60/I20-40, BEA28-120/I16-40, BEA28-100/I16-40, BEA28-80/I16-40, BEA28-60/I16-40, BEA28-120/I13-40, BEA28-100/I13-40, BEA28-80/I13-40, BEA28-60/I13-40, BEA28-110/I20-30, BEA28-90/I20-30, BEA28-70/I20-30, BEA28-50/I20-30, BEA28-110/I16-30, BEA28-90/I16-30, BEA28-70/I16-30, BEA28-50/I16-30, BEA28-100/I20-55, BEA28-80/I20-55, BEA28-100/I16-55, BEA28-80/I16-55), AFX Proximal Extensions (A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A28-28/C95, A31-31/C80, A31-31/C100, A34-34/C80, A34-34/C100, A22-22/C55-O20, A22-22/C75-O20, A22-22/C95-O20, A25-25/C55-O20, A25-25/C75-O20, A25-25/C95-O20, A28-28/C55-O20, A28-28/C75-O20, A28-28/C95-O20, A31-31/C80-O20, A31-31/C100-O20, A34-34/C80-O20, A34-34/C100-O20), AFX Vela Proximal Endograft System (A22-22/C75 V, A22-22/C95 V, A25-25/C75 V, A25-25/C95 V, A28-28/C75 V, A28-28/C95 V, A31-31/C80 V, A31-31/C100 V, A34-34/C80 V, A34-34/C100 V, A22-22/C75-O20 V, A22-22/C95-O20 V, A25-25/C75-O20 V, A25-25/C95-O20 V, A28-28/C75-O20 V, A28-28/C95-O20 V, A31-31/C80-O20 V, A31-31/C100-O20 V, A34-34/C80-O20 V, A34-34/C100-O20 V), AFX Limb Extensions (I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I20-20/C55, I20-20/C55F, IS20-25/C55, IF20-25/C65, IS20-25/C65), AFX Stand-Alone Limb Extensions (I16-16/C55 SA, I16-16/C55F SA, I16-16/C88 SA, I20-13/C70F SA, I20-13/C88F SA, I20-20/C55 SA, I20-20/C55F SA, IS20-25/C55 SA, IF20-25/C65 SA, IS20-25/C65 SA)
AFX2 分叉内移植系统 (BEA22-120/I20-40、BEA22-100/I20-40、BEA22-80/I20-40、BEA22-60/I20-40、BEA22-120/I16-40、BEA22-100/I16-40、BEA22-80/I16-40、BEA22-60/I16-40、BEA22-120/I13-40、BEA22-100/I13-40、BEA22-80/I13-40、BEA22-60/I13-40、BEA22-1 10/I20-30, BEA22-90/I20-30, BEA22-70/I20-30, BEA22-50/I20-30, BEA22-110/I16-30, BEA22-90/I16-30, BEA22-70/I16-30, BEA22-50/I16-30, BEA22-100/I20-55, BEA22-80/I20-55, BEA22-100/I16-55, BEA22-80/I16-55, BEA25-120/I20-40, BEA25-100/I20-40, BEA25-80/I20-40, BEA25-60/I20-40, BEA25-120/I16-40, BEA25-100/I16-40, BEA25-80/I16-40, BEA25-60/I16-40, BEA25-120/I13-40, BEA25-100/I13-40, BEA25-80/I13-40, BEA25-60/I13-40, BEA25-110/I20-30, BEA25-90/I20-30, BEA25-70/I20-30, BEA25-25-50/I20-30, BEA25-110/I16-30, BEA25-90/I16-30, BEA25-70/I16-30, BEA25-50/I16-30, BEA25-100/I20-55, BEA25-80/I20-55, BEA25-100/I16-55, BEA25-80/I16-55, BEA28-120/I20-40, BEA28-100/I20-40, BEA28-80/I20-40, BEA28-60/I20-40, BEA28-120/I16-40,BEA28-100/I16-40, BEA28-80/I16-40, BEA28-60/I16-40, BEA28-120/I13-40, BEA28-100/I13-40, BEA28-80/I13-40, BEA28-60/I13-40, BEA28-110/I20-30, BEA28-90/I20-30, BEA28-70/I20-30, BEA28-50/I20-30, BEA28-110/I16-30, BEA288 -90/I, 16-30, BEA28-70/I16-30, BEA28-50/I16-30, BEA28-100/I20-55, BEA28-80/I20-55, BEA28-100/I16-55, BEA28-80/I16-55), AFX 近端延伸 (A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A28-28/C95, A31-31/C80, A31-31/C100, A34-34/C80, A34-34/C100, A22-22/C55-O20, A22-22/C75-O20, A22-22/C95-O20, A25-25/C55-O20, A25-25/C75-O20, A25-25/C95-O20, A28-28/C55-O20, A28-20 8/C75-O20, A28-28/C95-O20, A31-31/C80-O20, A31-31/C100-O20, A34-34/C80-O20, A34-34/C100-O20), AFX Vela 近端内窥镜系统 (A22-22/C75 V, A22-22/C95 V, A25-25/C75 V, A25-25/C95 V, A28-28/C75 V, A28-28/C95 V、A31-31/C80 V、A31-31/C100 V、A34-34/C80 V、A34-34/C100 V、A22-22/C75-O20 V、A22-22/C95-O20 V、A25-25/C75-O20 V、A25-25/C95-O20 V、A28-28/C75-O 20 V, A28-28/C95-O20 V, A31-31/C80-O20 V, A31-31/C100-O20 V, A34-34/C80-O20 V, A34-34/C100-O20 V), AFX 肢体延伸 (I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F、I20-20/C55、I20-20/C55F、IS20-25/C55、IF20-25/C65、IS20-25/C65)、AFX 独立肢体伸展(I16-16/C55 SA、I16-16/C55F SA、I16-16/C88 SA、I20-13/C70F SA、I20-13/C88F SA、I20-20/C55 SA、I20-20/C55F SA、IS20-25/C55 SA、IF20-25/C65 SA、IS20-25/C65 SA)
About this record

This profile provides complete Hong Kong MDACS registration information for Procedure Kit/Trays, Implant Delivery, Stent, Vascular, Aorta Dissection. 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: Procedure Kit/Trays, Implant Delivery, Stent, Vascular, Aorta Dissection

產品資訊： 手术套件/托盘、植入物输送、支架、血管、主动脉夹层