SmartLyte Plus Electrolyte Analyzer and Accessories - Indonesia BPOM Medical Device Registration
SmartLyte Plus Electrolyte Analyzer and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102420139. The device is manufactured by DIAMOND DIAGNOSTICS, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GANDASARI EKASATYA.
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
DIAMOND DIAGNOSTICS, INC.Country of Origin
United States
Authorized Representative
PT. GANDASARI EKASATYAAR Address
Jl. Raya HANKAM No.9A RT.007/002 Kel. Bambu Apus, Kec. Cipayung 13890
Registration Date
Jul 29, 2024
Expiry Date
Feb 28, 2028
Product Type
Clinical Laboratory Equipment
Electrolyte analyzer
Invitro Diagnostics
BDI Lab Lyte Plus Electrolyte Analyzer and Accessories
BDI Lab Electrode Conditioning Solution
DIAMOND Wash Pack
DIAMOND Ca++ Electrode
DIAMOND Na+ Electrode
DIAMOND Cl- Electrode
DIAMOND K+ Electrode
DIAMOND ISE Cleaning Solution
DIAMOND Deproteinizer Solution
DIAMOND Electrode Conditioning Solution
COPAN MSwab
COPAN ITALIA S.P.A
NIHON PER Hemolynac-310
NIHON KOHDEN TOMIOKA CORPORATION
NIHON PER Isotonac 3 Diluent
NIHON KOHDEN TOMIOKA CORPORATION
NIHON KOHDEN MEK-680 Hemolynac 3N Lysing Reagent
NIHON KOHDEN TOMIOKA CORPORATION
CELLTACฮฑ AUTOMATED HEMATOLOGY ANALYZER MEK-1302 and Accessories
NIHON KOHDEN TOMIOKA CORPORATION
CELLTAC ฮฑ+ AUTOMATED HEMATOLOGY AND ESR ANALYZER MEK-1305 and Accessories
NIHON KOHDEN TOMIOKA CORPORATION
NIHON KOHDEN Automated Hematology Analyzer MEK-1301 Celltac ฮฑ and Accessories
NIHON KOHDEN TOMIOKA CORPORATION
CELLTAC G+ Automated Hematology Analyzer MEK-9200 and Accessories
NIHON KOHDEN TOMIOKA CORPORATION TOMIOKA PRODUCTION CENTER AND TOMIOKA OFFICE
NIHON PER Hemolynac - 510
NIHON KOHDEN TOMIOKA CORPORATION.
NIHON PER Reticulonac MK-110W
NIHON KOHDEN TOMIOKA CORPORATION

