Pure Global

NC EMERGE™ Monorail™ PTCA Dilatation Catheter - Indonesia BPOM Medical Device Registration

NC EMERGE™ Monorail™ PTCA Dilatation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20505126388. The device is manufactured by BOSTON SCIENTIFIC MEDICAL DEVICE (MALAYSIA) SDN BHD from Malaysia, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BOSTON SCIENTIFIC INDONESIA.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : C
NC EMERGE™ Monorail™ PTCA Dilatation Catheter
Analysis ID: AKL 20505126388

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Malaysia

Authorized Representative

PT. BOSTON SCIENTIFIC INDONESIA

AR Address

Prudential Tower lantai 28 Jl. Jend. Sudirman Kav. 79

Registration Date

Oct 27, 2021

Expiry Date

Jan 26, 2026

Product Type

Therapeutic Cardiology Equipment

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing