Prelude IDEAL™ HYDROPHILIC Sheath Introducer - Indonesia BPOM Medical Device Registration
Prelude IDEAL™ HYDROPHILIC Sheath Introducer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501420025. The device is manufactured by MERIT MEDICAL SYSTEMS, INC, from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is REKAMILENIUMINDO IN ACCORDANCE.
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
MERIT MEDICAL SYSTEMS, INC,Country of Origin
United States
Authorized Representative
REKAMILENIUMINDO IN ACCORDANCEAR Address
Jl. Tomang Raya No. 51B RT 01 RW 05, Kelurahan Tomang
Registration Date
Jan 12, 2024
Expiry Date
Dec 31, 2025
Product Type
Diagnostic Cardiology Equipment
Catheter introducer.
Non Electromedic Sterile
PRELUDE® SHEATH INTRODUCER
Prelude IDEAL™ HYDROPHILIC Sheath Introducer
CONCIERGE Guiding Excellence ™ Judkins Right Catheters
CONCIERGE Guiding Excellence Guiding Catheter SBS
CONCIERGE Guiding Excellence Guiding Catheter Multipurpose
MERIT ADVANCE Angiographic Needles
MERIT PURSUE ™ Microcatheter
MERIT Manifold
PRELUDE SHEATH INTRODUCER
MARQUIS Stopcock
MEDIINTERV Ventricular Septal Defect (VSD) Occluder
STARWAY MEDICAL TECHNOLOGY, INC.
PRELUDE® SHEATH INTRODUCER
MERIT MEDICAL SYSTEMS, INC,
Prelude +NEEDLE SHEATH INTRODUCER
MERIT MEDICAL SYSTEMS, INC.
Prelude IDEAL™ HYDROPHILIC Sheath Introducer
MERIT MEDICAL SYSTEMS, INC,
RAD PASS Micro Catheter
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD
MERIT MEDICAL Angioplasty Pack Honor® Hemostasis Valve
MERIT MAQUILADORA MEXICO, S.DE R.L DE C.V,
MEDIINTERV Occluder Delivery System
STARWAY MEDICAL TECHNOLOGY, INC.
MEDIINTERV Patent Ductus Arteriosus (PDA) Occluder
STARWAY MEDICAL TECHNOLOGY INC
MEDIINTERV Atrial Septal Defect (ASD) Occluder
STARWAY MEDICAL TECHNOLOGY INC
CONCIERGE Guiding Excellence Guiding Catheter SBS
MERIT MEDICAL SYSTEMS, INC,