Tracker-X Balloon Catheter - Indonesia BPOM Medical Device Registration

Tracker-X Balloon Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501321136. The device is manufactured by GS MEDICAL CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FAJAR SELARAS PARTNERS.

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 : C

Tracker-X Balloon Catheter

Analysis ID: AKL 20501321136

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

GS MEDICAL CO., LTD.

Country of Origin

Korea

Authorized Representative

PT. FAJAR SELARAS PARTNERS

AR Address

Komplek Rukan PTC Blok 8C No. 28-29 Pulogadung Tel. 021-46827776 Fax. 021-46827033

Registration Date

Nov 13, 2023

Expiry Date

Jul 13, 2026

Product Type

Diagnostic Cardiology Equipment

Percutaneous catheter.

Non Electromedic Sterile

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Tracker-X Balloon Catheter - Indonesia BPOM Medical Device Registration

Risk Classification

Product Class

Manufacturer

Country of Origin

Authorized Representative

AR Address

Registration Date

Expiry Date

Product Type

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