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GUARDIAN™ Sensor (3) - Indonesia BPOM Medical Device Registration

GUARDIAN™ Sensor (3) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101025462. The device is manufactured by MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is 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 : C
GUARDIAN™ Sensor (3)
Analysis ID: AKL 20101025462

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

MEDTRONIC INDONESIA

AR Address

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda, Desa/Kelurahan Kebayoran Lama Utara, Kec. Kebayoran Lama

Registration Date

Feb 20, 2024

Expiry Date

Feb 06, 2028

Product Type

Clinical Chemistry Test System

Glucose test system (strip & midstream)

Non Radiation Electromedics

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