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.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ZHEJIANG ORIENT GENE BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
PT. MEDICAL ERA ALKESINDOAR 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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