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SAFE SHEATH (HLS series) - Indonesia BPOM Medical Device Registration

SAFE SHEATH (HLS series) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501413224. The device is manufactured by MERIT MEDICAL SYSTEMS INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MEDTRONIC 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.

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BPOM Registered
Risk Class Kelas Resiko : B
SAFE SHEATH (HLS series)
Analysis ID: AKL 20501413224

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. MEDTRONIC INDONESIA

AR Address

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda

Registration Date

Sep 12, 2020

Expiry Date

Mar 12, 2025

Product Type

Diagnostic Cardiology Equipment

Catheter introducer.

Non Electromedic Sterile

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