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Perangkat kardiovaskular medis Lepu Mencapai otorisasi pemasaran di Arab Saudi

2021-08-24
LEPU
Perangkat kardiovaskular medis Lepu Mencapai otorisasi pemasaran di Arab Saudi

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 Arab Saudi legally.    

Lepu Medical Cardiovascular Devices Attain Marketing Authorization in Arab Saudi  


A total of 12 PCI products received the marketing authorization, covering Kateter angiografiKawat panduanSheath perkenalan, and Aksesori. Sampai tanggal status pendaftaran perangkat seri kardiovaskular Lepu medis di Arab Saudi adalah sebagai berikut:

 

SN.

Produk

Fitur

Arab Saudi
SFDA

1

Mitra™Sistem Stent koroner Cyrillic-Upping

Persetujuan CE, 2 juta Republik, Diameter 2.5-4mm, panjang 12-36mm;

SEDANG DIPROSES

2

H-stent™Sistem Stent koroner

Persetujuan CE, Diameter 2.5-4.0mm, panjang 9-36mm;

SEDANG DIPROSES

3

Nano™Sistem Stent koroner Sirolimus

Cina NMPA diakui; Diameter 2.5-4.0mm, panjang 12-36mm;

SEDANG DIPROSES

4

Gueatt™Sistem Stent koroner ekstrak CoCr sirolimus-extract

NMPA Cina disetujui; L605 CoCr Alloy; Diameter 2.5 "-4.0mm, panjang 12-36mm;

SEDANG DIPROSES

5

Hoper™Kateter dilapis balon PTCA

Persetujuan CE USFDA; semi sesuai; diameter 1.5-4.0mm, panjang 9-30mm; Tekanan Nominal 8atm, RBP 16atm;

Ya

6

Mini-tadpoles™Kateter menipiskan koroner

Persetujuan CE; semi sesuai; 1.2-2.0mm, panjang 6-30mm;

Ya

7

Tadpoles™Kateter menipiskan koroner

Persetujuan CE; semi sesuai; diameter 2.25-4.0mm, panjang 6-30mm;

Ya

8

NC Tadpole™Kateter dildo balon PTCA tidak sesuai

Disetujui CE; RBP 22atm tinggi; Poros distal hidrofilik; diameter 1.5 "-5.0mm, panjang 6-30mm

Ya

9

Shoocin™Peralatan perbicara FS

Persetujuan CE USFDA; Sistem penguncian Luer; Ukuran selubung 4-11F, panjang 5cm,11cm;

Ya

10

Shoocin™Peralatan perbicara RS

Persetujuan CE USFDA; Sistem penguncian Luer; Ukuran selubung 4-7F, panjang 5cm,7cm,11cm,24cm;

Ya

11

Brilian™Peralatan perbicara RS

Persetujuan CE USFDA; Kawat panduan hidrofilik; Sistem pengunci Luer; Ukuran selubung 4-7F, panjang 5cm, 7cm,11cm,24cm;

Ya

12

Orien™Kateter pemandu

CE penerus; Tipe kurva JL, AL, pencadangan ekstra, JR, AR; Ukuran 5F 6F 7F;

Ya

13

Rayband™Turniket kompresi arteri Radial

Persetujuan CE USFDA; Sistem pengunci Luer; Desain deflasi presisi 2ml.

Ya

14

Angiopower™Alat inflasi

Persetujuan CE USFDA; Tekanan s/d 30atm, rilis pemicu cepat, tampilan tekanan analog/neon

Ya

15

Ultraskin™Kawat panduan hidrofilik

Persetujuan CE USFDA; Diameter 0.018-0.035; Panjang 150-260cm; Melengkung lurus, 135 ° bersudut; Ujung dapat membentuk kembali tersedia;

Ya

16

Kawat panduan Balancium

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;

Ya

17

Angioway™Set katup y-hemostasis

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

Ya

18

Angioway™Pipa ekstensi tekanan tinggi

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

Ya

19

Angioway™Manifold

Persetujuan CE; Port samping 2/3; Tekanan 500psi; Katup Tyepe On/Off; Pipa ekstensi opsional

Ya

20

Musim semi anjio™Jarum suntik kontrol angiografi

Persetujuan CE; Plunger Solid dan halus; Skala bening; Bebas lateks; Kapasitas 12ml; Konektor putar;

Ya

21

Angiospring™Kit Manifold injeksi Medium kontras

CE persetujuan; Termasuk Manifold Angiopraphy kontrol jarum suntik Hige tekanan ekstensi Tubing Set infusi

Ya

22

Supercross™Kateter dilatasi balon PTA

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;

Ya

23

Thromsweeper™Kateter ekstraksi trombus

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;

Ya

24

Vesccide™Sistem pemotong balon

Persetujuan NMPA Tiongkok, 3 pisau/4 pisau, diameter 2.0 "-4.0mm, panjang 5mm, 10mm dan 15mm;

SEDANG DIPROSES

  

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 Arab Saudi. Should you have any questions, please feel free to contact Marketing@lepu-medical.com.

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