Celsius Thermocool Electrophysiology Catheter - Indonesia BPOM Medical Device Registration
Celsius Thermocool Electrophysiology Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501321226. The device is manufactured by BIOSENSE WEBSTER, INC. from Mexico, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is JOHNSON AND JOHNSON INDONESIA TWO.
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
BIOSENSE WEBSTER, INC.Country of Origin
Mexico
Authorized Representative
JOHNSON AND JOHNSON INDONESIA TWOAR Address
K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A, Kuningan, Setiabudi, Jakarta Selatan, Desa/Kelurahan Kuningan Timur, Kec. Setiabudi, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12950
Registration Date
Dec 20, 2023
Expiry Date
Dec 08, 2027
Product Type
Diagnostic Cardiology Equipment
Electrode recording catheter or electrode recording probe.
Non Electromedic Sterile
EZ STEER THERMOCOOL Bi-Directional Electrophysiology Catheter
EZ STEER THERMOCOOL NAV BI-Directional Electrophysiology Catheter
WEBSTER Duo-Decapolar Electrophysiology Catheter
NAVISTAR Electrophysiology Catheter
EZ STEER Bi-Directional Electrophysiology Catheter
WEBSTER Electrophysiology Catheter (Fixed Curved)
WEBSTER Electrophysiology Catheter (Deflectable Catheter)
HALO XP Electrophysiology Catheter
LASSO 2515 NAV Eco VARIABLE Catheter
PENTARAY NAV Eco High Density Mapping Catheter
ECHELON 3000 60mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ECHELON 3000 60mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ECHELON 3000 60mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ECHELON 3000 45mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ECHELON 3000 45mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ECHELON 3000 45mm Stapler
NYPRO HEALTHCARE BAJA, INC.
ATTUNE All Poly Tibia
DEPUY ORTHOPAEDICS, INC.
HARMONIC 700 Shears
NPA DE MEXICO S, DE R.L DE C.V.
CORAIL HIP SYSTEM - Corail Revision Femoral Stem
VIANT CHAUMONT SAS
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (Bi-Directional)
ETHICON, LLC.

