PREFACE Guiding Sheath - Indonesia BPOM Medical Device Registration
PREFACE Guiding Sheath is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501021784. The device is manufactured by CARDINAL HEALTH MEXICO 244 S DE RL DE CV from Mexico, and is classified as Risk Class Kelas Resiko : B. 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 : 2
Manufacturer
CARDINAL HEALTH MEXICO 244 S DE RL DE CVCountry of Origin
Mexico
Authorized Representative
PT. JOHNSON & JOHNSON NEW ZEALANDAR Address
K-LINK TOWER LT.12, JL. JEND. GATOT SUBROTO KAV.59 A.
Registration Date
Aug 31, 2023
Expiry Date
Aug 27, 2024
Product Type
Diagnostic Cardiology Equipment
Catheter introducer.
Non Electromedic Sterile
TEMPO Angiographic Catheter
ADROIT ™ Guiding Catheter
PREFACE Guiding Sheath
RAIN Sheath™ Transradial Introducer
EXOSEAL Vascular Closure Device
S.M.A.R.T CONTROL ™ Nitinol Stent System
AVANTI®+ Catheter Sheath Introducers
OPTEASE Retrieval Catheter
OPTEASE Retrievable Vena Cava Filter
PRECISE PRO RX Nitinol Stent System
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.
PROLENE Polypropylene Monofilament Non-Absorbable Suture
ETHICON INC.
DERMABOND PRINEO Skin Closure System
ETHICON LLC.
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device
ETHICON INC.