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ORIEN™ Guiding Catheter (Without Hole) - Indonesia BPOM Medical Device Registration

ORIEN™ Guiding Catheter (Without Hole) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20505710433. The device is manufactured by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MAIN REVASS MEDIKA.

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
ORIEN™ Guiding Catheter (Without Hole)
Analysis ID: AKL 20505710433

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. MAIN REVASS MEDIKA

AR Address

Jl. Dewi Sartika No. 4B RT 004/007 Kel. Cililitan Kec. Kramat jati

Registration Date

Oct 06, 2023

Expiry Date

Jun 07, 2028

Product Type

Diagnostic Cardiology Equipment

Percutaneous catheter.

Non Electromedic Sterile

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