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ACCU-CHECK Guide Test Strips - Indonesia BPOM Medical Device Registration

ACCU-CHECK Guide Test Strips is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101716528. The device is manufactured by ROCHE DIABETES CARE, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ROCHE 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
ACCU-CHECK Guide Test Strips
Analysis ID: AKL 20101716528

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. ROCHE INDONESIA

AR Address

Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi

Registration Date

Nov 15, 2021

Expiry Date

Sep 23, 2026

Product Type

Clinical Chemistry Test System

Glucose test system (strip & midstream)

Invitro Diagnostics

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