Medical Device Division · registration 170032Expired

Endologix

Name: Endologix — Medical Device Division 170032
Creator: Endologix International Holdings B.V.
Keywords: Endologix, Endologix, 170032, Procedure Kit/Trays, Implant Delivery, Stent, Vascular, Aorta Dissection, Medical Device Division

Hong KongProcedure Kit/Trays, Implant Delivery, Stent, Vascular, Aorta DissectionClass IVEndologix International Holdings B.V.

Verified

Official record identity

MDACS listing number: 170032
Model name: 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)
Registration date: November 09, 2018
Expiry date: March 10, 2022
Source update date: January 17, 2022
Status: Expired

Classification

Risk class: Class IV
Published category: Procedure Kit/Trays, Implant Delivery, Stent, Vascular, Aorta Dissection

Published parties

Registrant / registration holder: Synapse Therapeutics Limited
Manufacturer: Endologix International Holdings B.V.

Official description

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

Additional source fields

AMD nomenclature code: 26789
Traditional Chinese local responsible person: 百谷醫療科技有限公司
Local responsible person phone: 31881638
Published manufacturer address: Burgemeester Burgerslaan 40, 5245 NH Rosmalen, The Netherlands
Published remarks: Expired.
Revision number: b

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.