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ONEHEALTH One Step Morphine Test Strip - Indonesia BPOM Medical Device Registration

ONEHEALTH One Step Morphine Test Strip is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103420243. The device is manufactured by ZHEJIANG ORIENT GENE BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MEDICAL ERA ALKESINDO.

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
ONEHEALTH One Step Morphine Test Strip
Analysis ID: AKL 20103420243

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. MEDICAL ERA ALKESINDO

AR Address

Jl. Sisingamangaraja Kilometer 10.8, Komplek Amplas Trade Centre Blok Mahoni nomor 08, Kota Medan, Provinsi Sumatera Utara, Kode Pos: 20148

Registration Date

Sep 13, 2024

Expiry Date

Sep 09, 2027

Product Type

Clinical Toxicology Test System

Morphine test system (strip & midstream)

Invitro Diagnostics

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