SKYLA Metabolic Panel - Indonesia BPOM Medical Device Registration
SKYLA Metabolic Panel is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101126321. 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 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
Rafa Topaz MainAR Address
Taman Buaran Indah I Blok U No. 242 Jl. Radin Inten II, Klender, Jakarta Timur
Registration Date
Oct 25, 2021
Expiry Date
May 01, 2024
Product Type
Clinical Chemistry Test System
Multi parameter clinical chemistry test system
Invitro Diagnostics
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SKYLAโข HB1 Lipid Panel
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