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Lepu Medical Cardiovascular Devices Attain Marketing Authorization in Saudi Arabia

Lepu Medical Cardiovascular Devices Attain Marketing Authorization in Saudi Arabia

Recently, Lepu Medical’s multiple PCI products received marketing authorization issued by Saudi Food and Drug Authority (SFDA), demonstrating that the authorized products can be marketed and sold to the Kingdom of Saudi Arabia legally.    

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A total of 12 PCI products received the marketing authorization, covering angiographic catheter, guide wires, introducer sheaths, and accessories. Till date the registration status of cardiovascular series devices of Lepu Medical in Saudi Arabia is as below:

 

SN.

Product

Features

Saudi Arabia
SFDA

1

Partner™ Sirolimus-eluting Coronary Stent System

CE approval, 2 million implantations, Diameter 2.5-4mm, length 12-36mm;

in process

2

H-Stent™ Coronary Stent System

CE approval, Diameter 2.5-4.0mm, length 9-36mm;

in process

3

Nano+™ Polymer-free Sirolimus-eluting Coronary Stent System

China NMPA approval; Diameter 2.5-4.0mm, length 12-36mm;

in process

4

GuReater™ CoCr Sirolimus-eluting Coronary Stent System

China NMPA approval; L605 CoCr Alloy; Diameter 2.5-4.0mm, length 12-36mm;

in process

5

Hoper™ PTCA Balloon Dilatation Catheter

USFDA CE approval; semi-compliant; diameter 1.5-4.0mm, length 9-30mm;Nominal pressure 8atm, RBP 16atm;

Yes

6

Mini-Tadpole™ Coronary Dilatation Catheter

CE Approval; semi-compliant; diameter 1.2-2.0mm, length 6-30mm;

Yes

7

Tadpole™ Coronary Dilatation Catheter

CE Approval; semi-compliant; diameter 2.25-4.0mm, length 6-30mm;

Yes

8

NC Tadpole™ Non Compliant PTCA Balloon Dilatation Catheters

CE approval; high RBP 22atm; hydrophilic distal shaft;diameter 1.5-5.0mm,length 6-30mm

Yes

9

Shoocin™ Introducer Kit FS

USFDA CE approval;Luer Locking System;sheath size 4-11F,length 5cm,11cm;

Yes

10

Shoocin™ Introducer Kit RS

USFDA CE approval;Luer Locking System;sheath size 4-7F,length 5cm,7cm,11cm,24cm;

Yes

11

Brilliant™ Introducer Kit RS

USFDA CE approval;Hydrophilic Guide Wire; Luer Locking System;sheath size 4-7F,length 5cm,7cm,11cm,24cm;

Yes

12

Orien™ Guiding Catheter

CE approval;Curve Type JL, AL, Extra Backup, JR, AR;Size 5F 6F 7F;

Yes

13

Rayband™ Radial Artery Compression Tourniquets

USFDA CE approval;Luer Locking System; 2ml precising deflation design

Yes

14

Angiopower™ Inflation Device

USFDA CE approval;pressure upto 30atm, rapid trigger release, analog/fluorescent pressure display

Yes

15

Ultraskin™ Hydrophilic Guide Wire

USFDA CE approval; Diameter 0.018-0.035; Length 150-260cm; Curve Straight, 135° Angled; Reshapable Tip available;

Yes

16

Balancium Guide Wire

CE approval; Design Core-to-Tip, Shaping Ribbon available; Diameter 0.014; Length 185cm, 300cm; Tip flexibility  0.6g, 1g and 2g available; Tip Shape Straight and J; Moderate Radial Support;

Yes

17

Angioway™ Y-Hemostasis Valve Set

USFDA CE approval; Push-pull/Rotating Type; I.D.: 0.018" (3.0mm); Body Material: polycarbonate; Optional Extension Tubing; Available with Whole Set Package Y Valve+Guide Wire Introducer+Guide Wire Torquer

Yes

18

Angioway™ High Pressure Extension Tubings

CE approval; Large Flow; Customized length available; 500psi / 1200psi; I.D.: 0.056" (1.44mm); Material PVC/TPU

Yes

19

Angioway™ Manifolds

CE approval; Side Port 2/3; Pressure 500psi; Valve Tyepe On/Off; Optional Extension Tubing

Yes

20

Angiospring™ Angiography Control Syringe

CE approval; Solid and Smooth Plunger; Clear Scale; Latex Free; Capacity 12ml; Rotating Connector;

Yes

21

Angiospring™ Contrast Medium Injection Manifold Kits

CE approval; Including Manifold+Angiopraphy Control Syringe+Hige Pressure Extension Tubing+Infusion Set

Yes

22

Supercross™ PTA Balloon Dilatation Catheter

CE approval; Both RX and OTW Available; Semi-compliant ; 2 Markers; Material Nylon 12 and 11; Nominal Pressure 7 atm; Distal Shaft 2.8 Fr; Proximal Shaft 2.3 Fr; Crossing Profile 0.026-0.030"; Usable Catheter Length PTAR 135cm, PTAO 80/135/190cm; Min. Guideing Catheter Compatibility for PTAR 5Fr/0.056"; Introducer Sheath Compatible for PTAO 6F/7F; Guidewire Compatible PTAR-0.014inch, PTAO 0.035inch;

Yes

23

Thromsweeper™ Thrombus Extraction Catheter

CE approval; Rapid Exchange compatibility 6F (0.070") guiding catheter, 0.014" guide wire, length 1450mm, extraction lumen area 1.03 mm², guidewire lumen length 113mm, catheter O.D. Proximal 1.27mm, Distal 1.50mm;

Yes

24

Vesscide™ Cutting Balloon System

China NMPA approval, 3 blades/4 blades, Diameters 2.0-4.0mm, Length 5mm, 10mm and 15mm;

in process

  

Lepu Medical will keep on addressing the global medical needs by providing high-quality and cost-effective products. For the details and features of the products, please visit: https://en.lepumedical.com/products/cardiovascular-products/  

 

We are now in the stage of building up distribution network, inviting capable channel partners nationwide to join our channel partners’ network, and bring the benefits of Lepu Medical cardiovascular devices and solutions to the patients and cardiologists of Saudi Arabia. Should you have any questions, please feel free to contact marketing@lepu-medical.com.