HIGHTOP SARS-CoV-2 Antigen Rapid Test (Swab) - Indonesia BPOM Medical Device Registration
HIGHTOP SARS-CoV-2 Antigen Rapid Test (Swab) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303125222. The device is manufactured by QINGDAO HIGHTOP BIOTECH CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SURYA SUKSES PERKASA.
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
QINGDAO HIGHTOP BIOTECH CO., LTDCountry of Origin
China
Authorized Representative
PT. SURYA SUKSES PERKASAAR Address
Jl. Paradise Timur Raya Blok F21 No. 52
Registration Date
Aug 03, 2022
Expiry Date
Apr 26, 2027
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
HIGHTOP Auto Hematology Analyzer
HIGHTOP Auto Hematology Analyzer
HIGHTOP Lyse II
HIGHTOP Diluent
HIGHTOP Lyse I
HIGHTOP Malaria P.f/P.v Rapid Test Kit
NewHIGHTOP Antigen Rapid Test Cassette
HIGHTOP SYPHILIS Ab Rapid Test
HIGHTOP Dengue NS1 Ag Rapid Test
HIGHTOP Dengue IgG/IgM Rapid Test
NEW 1.2 JUN NUO Disposible Virus Specimen Collection Tube
SHANDONG CHENGWU MEDICAL PRODUCTS FACTORY
XABI MagXtractor Automatic Nucleic Acid Extractor
MERLIN BIOMEDICAL (XIAMEN) CO., LTD.
HUIAN Disposable Virus Sampling Tube Kit
SHENZHEN HUIAN BIOSCI TECHNOLOGY CO., LTD.
XABI DNA/RNA Extraction Kit (Magnetic Bead , Automation)
MERLIN BIOMEDICAL (XIAMEN) CO.,LTD
JN Finger Clip Pulse Oximeter
SHENZHEN JIANGNAN MEDICAL TECHNOLOGY CO.LTD.,
NEW 1.2 JUN NUO Disposible Virus Specimen Collection Tube
SHANDONG CHENGWU MEDICAL PRODUCTS FACTORY

