Pure Global

SKYLA Clinical Chemistry Analyzer - Indonesia BPOM Medical Device Registration

SKYLA Clinical Chemistry Analyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102126472. The device is manufactured by SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH from Taiwan (China), and is classified as Risk Class Kelas Resiko : B. 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
SKYLA Clinical Chemistry Analyzer
Analysis ID: AKL 20102126472

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Taiwan (China)

Authorized Representative

Rafa Topaz Main

AR Address

Taman Buaran Indah I Blok U No. 242 Jl. Radin Inten II, Klender, Jakarta Timur

Registration Date

Oct 28, 2021

Expiry Date

May 01, 2024

Product Type

Clinical Laboratory Equipment

Instrumentation for clinical multiplex test systems.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing