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MEDINAUT-X (IBE System) Balloon Catheter - Indonesia BPOM Medical Device Registration

MEDINAUT-X (IBE System) Balloon Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20805320813. The device is manufactured by IMEDICOM 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
MEDINAUT-X (IBE System) Balloon Catheter
Analysis ID: AKL 20805320813

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

IMEDICOM 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

Jun 27, 2023

Expiry Date

Dec 23, 2027

Product Type

Therapeutic Gastroenterology-Urology Equipment

Urological catheter and accessories.

Non Electromedic Sterile

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