Perangkat kardiovaskular medis Lepu Mencapai otorisasi pemasaran di Arab Saudi
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2021-08-24
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LEPU
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.
A total of 12 PCI products received the marketing authorization, covering Kateter angiografi, Kawat panduan, Sheath perkenalan, and Aksesori. Sampai tanggal status pendaftaran perangkat seri kardiovaskular Lepu medis di Arab Saudi adalah sebagai berikut:
SN. | Produk | Fitur | Arab Saudi |
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.
