BIOEASY ™ ONE STEP Malaria (P.F/P.V) Tri-line Rapid Test - Indonesia BPOM Medical Device Registration
BIOEASY ™ ONE STEP Malaria (P.F/P.V) Tri-line Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303918204. The device is manufactured by SHENZHEN BIOEASY BIOTECHNOLOGY CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. LANIROS DIAN PHARMA.
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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZHEN BIOEASY BIOTECHNOLOGY CO., LTDCountry of Origin
China
Authorized Representative
PT. LANIROS DIAN PHARMAAR Address
GEDUNG SATRIO TOWER LT. 22, JL. PROF. DR. SATRIO KAV. C4
Registration Date
Dec 12, 2019
Expiry Date
Jun 20, 2024
Product Type
Serological Reagents
Plasmodium species antigen detection assays
Invitro Diagnostics
BIOEASY™ ONE STEP BZO (Oxazepam) Rapid Test Strip
BIOEASY™ ONE STEP BAR (Secobarbital) Rapid Test Strip
BIOEASY™ ONE STEP MOP (Morphine) Rapid Test Strip
BIOEASY™ ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test
BIOEASY ™ ONE STEP Multi-drug Dip Card (9 Drugs): THC/MOP/AMP/MET/BZO/COC/K2/ETG/PCP
BIOEASY ™ ONE STEP Multi-drug Dip Card (10 Drugs): THC/MOP/AMP/MET/BZO/COC/K2/ETG/PCP/TRA
BIOEASY™ ONE STEP Dengue IgG/IgM - NS1 Combo Test
BIOEASY ™ ONE STEP Multi-drug Dip Card (3 Drugs): MOP/THC/AMP
BIOEASY ™ ONE STEP Multi-drug Dip Card (3 Drugs): THC/AMP/BZO
BIOEASY ™ ONE STEP Multi-drug Dip Card (7 Drugs): THC/MOP/AMP/MET/BZO/COC/K2
Woman Choice+ Early Detection Pregnancy Test Midstream
ARTRON LABORATORIES INC.
Woman Choice+ Early Detection Pregnancy Test Strip
ARTRON LABORATORIES INC.
CLIMAX Multitexture Condom
MHL HEALTHCARE LIMITED
CLIMAX Plain Condom
MHL HEALTHCARE LIMITED
SENSOR Multi-Drug 7 Drugs Rapid Test Panel (THC50/MOP300/AMP1000/MET500/COC300/BZO300/CAR)
HANGZHOU ALLTEST BIOTECH CO., LTD.
SENSOR Multi-Drug 6 Drugs Rapid Test Panel (THC50/AMP1000/MET500/BZO300/COC300/MOP300)
HANGZHOU ALLTEST BIOTECH CO., LTD.
SENSOR Multi-Drug 10 Drugs Rapid Test Panel (THC50/MOP300/AMP1000/MET500/COC300/BZO300/K2/ETG/CAR/PCP)
HANGZHOU ALLTEST BIOTECH CO., LTD.
STAR DIAGNOSTIC PLUS HBsAg Strip Test
ARTRON LABORATORIES INC.
STAR DIAGNOSTICS Dengue IgG/IgM Rapid Test Cassette
HANGZHOU ALLTEST BIOTECH CO., LTD.
STAR DIAGNOSTICS Dengue NS1 Rapid Test Cassette
HANGZHOU ALLTEST BIOTECH CO., LTD.

