SKYLA™ HB1 Lipid Panel - Indonesia BPOM Medical Device Registration
SKYLA™ HB1 Lipid Panel is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101127261. The device is manufactured by SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH from Taiwan (China), and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. RAFA TOPAZ MAIN.
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
SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCHCountry of Origin
Taiwan (China)
Authorized Representative
PT. RAFA TOPAZ MAINAR Address
Taman Buaran Indah I Blok U No. 242 Jl. Radin Inten II, Klender, Jakarta Timur
Registration Date
Nov 24, 2021
Expiry Date
May 01, 2024
Product Type
Clinical Chemistry Test System
Multi parameter clinical chemistry test system
Invitro Diagnostics
SKYLA ™ Hi CRP Reagent Kit
SKYLA Renal Panel
COVER YOUR PANEL
SKYLA Clinical Chemistry Analyzer
SKYLA Metabolic Panel
SKYLA Hi Analzyer and Accessories
SKYLA General Biochemistry Panel
SKYLA Liver Panel
LABSTRIP U11 Plus Urinalysis
77 ELECTRONICS LTD.
LABSTRIPS U11 Plus GL Urine Test Strip
77 ELECTRONICS LTD.
LabUReader Plus 2 semi-automated urine analyzer
77 ELECTRONICS LTD
LABUMAT 2 Automated Urine Chemistry Analyzer
77 ELECTRONICS LTD.
URISED 3 Automated Urine Sediment Analyzer
77 ELECTRONICS LTD.
DocUReader 2 Pro Urine Analyzer and Accessories
77 ELECTRONICS LTD.
URISED Mini Urine Sediment Analyzer and Accessories
77 ELECTRONICS LTD.
LORNE RPR Carbon Kit
LORNE LABORATORIES LIMITED
LORNE Anti-B Monoclonal Blood Grouping Reagent
LORNE LABORATORIES LIMITED
LORNE Anti-D Duoclone Monoclonal
LORNE LABORATORIES LIMITED.

