Pure Global

HISCL Troponin T hs Calibrator - Indonesia BPOM Medical Device Registration

HISCL Troponin T hs Calibrator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101612957. The device is manufactured by SYSMEX CORPORATION, SEISHIN FACTORY. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SYSMEX INDONESIA.

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
HISCL Troponin T hs Calibrator
Analysis ID: AKL 20101612957

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Japan

Authorized Representative

PT. SYSMEX INDONESIA

AR Address

Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13

Registration Date

Jul 24, 2023

Expiry Date

Jan 16, 2028

Product Type

Clinical Chemistry Test System

Calibrator (cair)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing