Pure Global

ABON Multi-Drug One Step Multi-Line Screen Test Device (Urine) (AMP/THC/MOP) - Indonesia BPOM Medical Device Registration

ABON Multi-Drug One Step Multi-Line Screen Test Device (Urine) (AMP/THC/MOP) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103515585. The device is manufactured by ABON BIOPHARM (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ALERE HEALTH.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : C
ABON Multi-Drug One Step Multi-Line Screen Test Device (Urine) (AMP/THC/MOP)
Analysis ID: AKL 20103515585

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. ALERE HEALTH

AR Address

K-Link Tower Lantai 18 Zona D, E, dan F Jl. Gatot Subroto Kav. 59 A RT 001 RW 003 Kel. Kuningan Timur, Kec. Setiabudi, Jakarta Selatan

Registration Date

Dec 08, 2022

Expiry Date

Jun 04, 2027

Product Type

Clinical Toxicology Test System

Multi parameter clinical toxicology test system

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing