ECLIA Analyzer Plus Scanner - Indonesia BPOM Medical Device Registration
ECLIA Analyzer Plus Scanner is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102127845. The device is manufactured by SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. UBC MEDICAL 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
SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. UBC MEDICAL INDONESIAAR Address
Jalan Rawa Gelam V, Blok L Kav. 11-13, Kawasan Industri Pulogadung Jakarta Timur13930
Registration Date
Dec 10, 2021
Expiry Date
Apr 29, 2026
Product Type
Clinical Laboratory Equipment
Instrumentation for clinical multiplex test systems.
Invitro Diagnostics
LIFOTRONIC Free Triiodothyronine Kit (Electrochemiluminescence Immunoassay)
LIFOTRONIC Free Thyroxine Kit (Electrochemiluminescence Immunoassay)
LIFOTRONIC Creatine Kinase MB (Electrochemiluminescence Immunoassay)
LIFOTRONIC Thyroid Peroxidase Antibody (Electrochemiluminescence Immunoassay)
LIFOTRONIC HBsAg (eCLIA)
LIFOTRONIC Ferritin (Electrochemiluminescence lmmunoassay)
LIFOTRONIC Diode Laser Hair Removal Machine
LIFOTRONIC 25-Hydroxy Vitamin D Test (FIA)
LIFOTRONIC fT4 Test (FIA)
LIFOTRONIC N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kits (Lateral Flow Immunoassay)
NEOBASE Non-derivatized MSMS Kit
WALLAC OY.
GSP Neonatal 17ฮฑ-OH Progesterone Kit
WALLAC OY
VICTOR 2D 1420 Multilabel Counter
WALLAC OY.
DELFIA Neonatal 17 Alfa OH Progesterone Kit
WALLAC OY
GSP Neonatal Phenylalanine Kit
WALLAC OY.
GSP Genetic Screening Processor
WALLAC OY.
GSP Neonatal G6PD Kit
WALLAC OY.
SciTropin A โข PEN 10
NEMERA SZCZECIN SP. Z O.O
DELFIA Inducer
WALLAC OY.
SciTropin A โข PEN 5
NEMERA SZCZECIN SP. Z O.O