PRUITT F3 Carotid Shunt - Indonesia BPOM Medical Device Registration
PRUITT F3 Carotid Shunt is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20504320151. The device is manufactured by LEMAITRE VASCULAR, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. GEM OF GRACE VIBRASA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
LEMAITRE VASCULAR, INC.Country of Origin
United States
Authorized Representative
PT. GEM OF GRACE VIBRASAAR Address
Perkantoran CBD Ciledug Jl. Hos Cokroaminoto No. 93 Ruko perkantoran CBD Ciledug Blok A3 No. 28
Registration Date
May 16, 2023
Expiry Date
Apr 21, 2026
Product Type
Surgical Cardiology Equipment
Cardiopulmonary bypass vascular catheter, cannula, or tubing.
Non Electromedic Sterile
LeMaitre LifeSpan ePTFE Vascular Graft
LeMaitre AlboGraft Polyester Vascular Graft
AnastoClip Atraumatic Forceps and Removers
LeMaitre Valvulotome System
LEMAITRE Glow 'N Tell Tape and Stent Guide
SYNTEL® Silicone Thrombectomy Catheter
TUFTEX Embolectomy Catheter
XENOSURE Biological Patch
HTKD Disposable Suture Holder
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE
OPI Abdominal Retractors
BOTHWIN (BEIJING) MEDICAL TECHNOLOGY CO., LTD
OPI Sternal Retractor
BOTHWIN (BEIJING) MEDICAL TECHNOLOGY CO., LTD
BEIEN Disposable Endoscopic Staplers and Reload Unit
WUXI BEIEN SURGERY DEVICE CO., LTD.
AnastoClip Atraumatic Forceps and Removers
LEMAITRE VASCULAR, INC.
LeMaitre Valvulotome System
LEMAITRE VASCULAR, INC.
TPRI Extra-Corporeal Circuit Tube
TIANJIN PLASTICS RESEARCH INSTITUTE CO., LTD.
DOWIN Hemostatic Forceps
DOWIN (BEIJING) MEDICAL TECHNOLOGY CO., LTD.,
DOWIN Retractors Fixtures
DOWIN (BEIJING) MEDICAL TECHNOLOGY CO., LTD.,
LEMAITRE Glow 'N Tell Tape and Stent Guide
LEMAITRE VASCULAR, INC.