AMPERE Generator - Indonesia BPOM Medical Device Registration
AMPERE Generator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30501024704. The device is manufactured by ST. JUDE MEDICAL from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. NUGRA KARSERA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
ST. JUDE MEDICALCountry of Origin
United States
Authorized Representative
PT. NUGRA KARSERAAR Address
Rukan Graha Mas Pemuda, Jalan Pemuda Blok AA/ 10
Registration Date
May 06, 2024
Expiry Date
Feb 06, 2029
Product Type
Diagnostic Cardiology Equipment
Cardiac ablation percutaneous catheter
Non Radiation Electromedics
AGILIS NxT โข Steerable Introducer
EnSite Velocity โข Cardiac Mapping System
WORKMATE CLARIS โข System Display Plus
LIVEWIREโข Steerable Electrophysiology Catheter
SWARTZ โข Braided Transseptal Guiding Introducer
Fast-Cath โข Hemostasis Introducer
LIVEWIREโข TC Ablation Catheter
Agilisโข NxT Steerable Introducer
PRESSUREWIREโข Receiver
ENSITE NAVX โข Surface Electrode Kit
TACTIFLEX โข Sensor Enabled โข Ablation Catheter
ABBOTT MEDICAL
TACTIFLEXโข Sensor Enabledโข Ablation Catheter
ABBOTT MEDICAL COSTA RICA LTDA
AXS Universal Aspiration Tubing
MEDELA AG
TactiSys โข Quartz Equipment
ABBOTT MEDICAL
NUGRA Hydrophilic Guide Wire
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.
ADVISOR โข VL Circular Mapping Catheter, Sensor Enabled โข
ABBOTT MEDICAL COSTA RICA LTDA
Z-MED โข Percutaneous Transluminal Valvulopasty Catheter
NUMED INC.
NUGRA Manifold
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.
NUGRA High Pressure Extension Tubing
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.
NUGRA Angiographic Catheter
LEPU MEDICAL TECHNOLOGY (BEIJING) CO,. LTD.

