GENTi Advanced Automatic Extraction Equipment - Indonesia BPOM Medical Device Registration
GENTi Advanced Automatic Extraction Equipment is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304320178. The device is manufactured by GENEALL BIOTECHNOLOGY CO., LTD., from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. STANDARD BIOSENSOR 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
GENEALL BIOTECHNOLOGY CO., LTD.,Country of Origin
Korea
Authorized Representative
PT. STANDARD BIOSENSOR INDONESIAAR Address
L'AVENUE BUILDING UNIT C, LT. 21, JL. RAYA PASAR MINGGU KAV. 16
Registration Date
Oct 25, 2023
Expiry Date
Dec 31, 2025
Product Type
Immunology Laboratory Equipment and Reagents
RNA Preanalytical Systems.
Invitro Diagnostics
STANDARD M10 DENV 1-4
SD BIOSENSOR
STANDARDโข F Vitamin D FIA
SD BIOSENSOR HEALTHCARE PVT. LTD
STANDARD F TSH-II FIA
SD BIOSENSOR
STANDARD Lipidocare Analyzer (NB)
SD BIOSENSOR
VIASURE Zika, Dengue & Chikungunya Real Time PCR Detection Kit
CERTEST BIOTEC S.L
STANDARDโข Q HCV Ab Test
SD BIOSENSOR INC.
STANDARD F Dengue IgM/IgG FIA and Accessories
SD BIOSENSOR.
STANDARDโข F hs-CRP
SD BIOSENSOR
STANDARD F U-Albumin FIA amd Accessories
SD BIOSENSOR.
STANDARD M10 MTB/NTM
SD BIOSENSOR

