EZ STEER THERMOCOOL Bi-Directional Electrophysiology Catheter - Indonesia BPOM Medical Device Registration
EZ STEER THERMOCOOL Bi-Directional Electrophysiology Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30501903138. The device is manufactured by BIOSENSE WEBSTER INC. from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. JOHNSON & JOHNSON NEW ZEALAND.
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 : 3
Manufacturer
BIOSENSE WEBSTER INC.Country of Origin
United States
Authorized Representative
PT. JOHNSON & JOHNSON NEW ZEALANDAR Address
K-Link Tower Lt. 12, Jln. Jend. Gatot Subroto Kav. 59 A
Registration Date
Sep 10, 2021
Expiry Date
Mar 18, 2026
Product Type
Diagnostic Cardiology Equipment
Cardiac ablation percutaneous catheter
Non Electromedic Sterile
QDOT MICRO Bi-Directional Navigation Catheter
QDOT MICRO Uni-Directional Navigation Catheter
LASSO Electrophysiology Catheter With Auto ID
LASSO® 2515 NAV eco VARIABLE CATHETER
CELSIUS FLTR Catheter
CELSIUS FLTR Catheter
NAVI-STAR Thermo-Cool Electrophysiology Catheter
THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter
THERMOCOOL SMARTTOUCH™ SF Bi-Directional Navigation Catheter
CARTO® 3 System External Reference Patches
PDS PLUS Antibacterial (Polydioxanone) Suture
ETHICON INC.
ETHIBOND EXCEL Coated Polyester
ETHICON, INC.
PROLENE Polypropylene Suture
ETHICON, INC
STRATAFIX Spiral PGA-PCL Knotless Tissue Control Device (Bi-Directional)
SURGICAL SPECIALTIES MEXICO, S. DE R.L. DE C.V.
STRATAFIX Spiral PDO Knotless Tissue Control Device (Bi-Directional)
SURGICAL SPECIALTIES MEXICO, S. DE R.L. DE C.V.
DERMABOND* Propen Topical Skin Adhesive
ETHICON LLC.
CARTO VIZIGO BI-DIRECTIONAL GUIDING SHEATH
FREUDENBERG MEDICAL LLC.
DERMABOND PRINEO Skin Closure System
ETHICON LLC.
PROLENE Polypropylene Monofilament Non-Absorbable Suture
ETHICON INC.
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device
ETHICON INC.