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FOXTROT PRO PTCA Balloon Catheter - Indonesia BPOM Medical Device Registration

FOXTROT PRO PTCA Balloon Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505420080. The device is manufactured by SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD. (NEWTON) from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. SURGIKA ALKESINDO.

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.

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BPOM Registered
Risk Class Kelas Resiko : D
FOXTROT PRO PTCA Balloon Catheter
Analysis ID: AKL 30505420080

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

China

Authorized Representative

PT. SURGIKA ALKESINDO

AR Address

Jl. Letjen Suprapto No.60, Gedung Indra Sentral unit G-H, Cempaka Putih

Registration Date

Jun 21, 2024

Expiry Date

May 29, 2026

Product Type

Therapeutic Cardiology Equipment

Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Non Electromedic Sterile

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