GENRUI Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) - Indonesia BPOM Medical Device Registration
GENRUI Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303120946. The device is manufactured by GENRUI BIOTECH INC. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BANDUNG SCIENTIFIC TECHNICAL INDONESIA.
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
GENRUI BIOTECH INC.Country of Origin
China
Authorized Representative
PT. BANDUNG SCIENTIFIC TECHNICAL INDONESIAAR Address
Jl. Cempaka Putih Raya No. 65D
Registration Date
Feb 08, 2024
Expiry Date
Dec 18, 2025
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
GENRUI Nucleic Acid Extraction Kit
GENRUI Fully-Auto Nucleic Acid Extraction Instrument
GENRUI C-Reactive Protein (CRP) Test Kit (Immunofluorescence)
GENRUI KT05A LH Lyse
GENRUI FA-50 Quantitative Immunoassay Reagents IL-6
GENRUI FA-50 Quantitative Immunoassay Reagents Thyroid Stimulating Hormone (TSH) Test Kit
GENRUI Procalcitonin (PCT) Test Kit
GENRUI Glycosylated Hemoglobin (HbA1c) Test Kit
GENRUI Thyroxine (T4) Test Kit
GENRUI Immunoassay Reagents Cardiac Troponin I (cTnl) Test Kit
GENRUI Nucleic Acid Extraction Kit
GENRUI BIOTECH INC.
GENRUI Fully-Auto Nucleic Acid Extraction Instrument
GENRUI BIOTECH INC.
SURGIMAX Surgical Instruments
SURGIMAX INSTRUMENT LIMITED
SURGIMAX Basic Total Hip Set
SURGIMAX INSTRUMENT LIMITED
SURGIMAX Appendectomy and Hernia Set
SURGIMAX INSTRUMENT LIMITED
SURGIMAX Closed Thoracostomy Set
SURGIMAX INSTRUMENT LIMITED
SURGIMAX – Dental Instrument Extraction Set Dl/201521
SURGIMAX INSTRUMENT LIMITED
SURGIMAX Dilattation and Curettage Set
SURGIMAX INSTRUMENT LIMITED.
SURGIMAX Minor Basic Instrument Set
SURGIMAX INSTRUMENT LIMITED
SURGIMAX - LAPAROSCOPY SET - LS20-400-22
SURGIMAX INSTRUMENT LIMITED