Pure Global
Singapore HSA registration DE0501956

Life Vascular iVascular luminor 35 Paclitaxel eluting PTA balloon dilatation catheter

Singapore flagSingapore·CLASS COM·LIFE VASCULAR DEVICES BIOTECH, S.L.·Registered July 27, 2018
Device classification
Device Class
CLASS COM
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0501956
Registration Date
July 27, 2018
Change Notification Approval Date
October 29, 2024
Retention Due Date
July 26, 2025
Product description
iVascular luminor 35 paclitaxel eluting dilatation balloon is indicated for dilation of stenosis located in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, whether original or artificial, with a reference diameter balloon from 5 to 7 mm and lengths from 20 to 150 mm. It is also indicated for stent postdilation in the peripheral vascular system.
Product Owner
Name
LIFE VASCULAR DEVICES BIOTECH, S.L.
Short Name
LIFE VASCULAR DEVICES BIOTECH, S.L.
Address
Cami de Can Ubach no11 Pol. Ind., Les Fallulles, Sant Vicenç dels Horts, 08620, Barcelona, SPAIN
Registrant
Name
IMPLANTEX PTE. LTD.
Address
HONGKONG STREET, HOLY BUILDING, #03-01, SINGAPORE 059675
Importer
Name
ZYFAS PHARMA PTE LTD
Address
102F PASIR PANJANG ROAD, CITILINK WAREHOUSE COMPLEX, #06-10, SINGAPORE 118530
Model information
Model Name(s)
iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35 iVascular luminor 35
Model Identifier(s)
BP DPC35 080 500 020 BP DPC35 080 500 040 BP DPC35 080 500 060 BP DPC35 080 500 080 BP DPC35 080 500 120 BP DPC35 080 500 150 BP DPC35 080 600 020 BP DPC35 080 600 040 BP DPC35 080 600 060 BP DPC35 080 600 080 BP DPC35 080 600 120 BP DPC35 080 600 150 BP DPC35 080 700 020 BP DPC35 080 700 040 BP DPC35 080 700 060 BP DPC35 080 700 080 BP DPC35 080 700 120 BP DPC35 140 500 020 BP DPC35 140 500 040 BP DPC35 140 500 060 BP DPC35 140 500 080 BP DPC35 140 500 120 BP DPC35 140 500 150 BP DPC35 140 600 020 BP DPC35 140 600 040 BP DPC35 140 600 060 BP DPC35 140 600 080 BP DPC35 140 600 120 BP DPC35 140 600 150 BP DPC35 140 700 020 BP DPC35 140 700 040 BP DPC35 140 700 060 BP DPC35 140 700 080 BP DPC35 140 700 120
About this record

Access comprehensive regulatory information for Life Vascular iVascular luminor 35 Paclitaxel eluting PTA balloon dilatation catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0501956 and owned by LIFE VASCULAR DEVICES BIOTECH, S.L.. The device was registered on July 27, 2018.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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