LABNOVATION Glycosylated Hemoglobin Test Reagent Kit (HPLC) - Indonesia BPOM Medical Device Registration
LABNOVATION Glycosylated Hemoglobin Test Reagent Kit (HPLC) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207220148. The device is manufactured by LABNOVATION TECHNOLOGIES, INC., from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.
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
LABNOVATION TECHNOLOGIES, INC.,Country of Origin
China
Authorized Representative
PT. FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Sep 27, 2022
Expiry Date
Jul 11, 2027
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
Invitro Diagnostics
Labnovation Hemoglobin A1c Test Kit (Boronate Affinity)
LABNOVATION WBC Lysis
Labnovation Lyser HGB
LABNOVATION LD-100 POCT HbA1c Analyzer
LABNOVATION MT-Diluent
LABNOVATION Cleaner MT
LABNOVATION MT-Lyse
LABNOVATION Rinse & HGB Reff
LABNOVATION Rinse NK
LABNOVATION RT-Lyse
SM MALB Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM Multi Control for Clinical Chemistry Analyzer Level 1
URIT MEDICAL ELECTRONIC CO., LTD
SM TB-DCA Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM DB-DCA Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM – 700 Automatic Chemistry Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
SM FC-73 Flow Cytometer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 3 Diff
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 5 Diff
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 5 Diff (Normal Level)
URIT MEDICAL ELECTRONIC CO., LTD
SM 420 Automatic Chemistry Analyzer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD