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HISCL™ TSH Assay Kit - Indonesia BPOM Medical Device Registration

HISCL™ TSH Assay Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101612895. 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.

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BPOM Registered
Risk Class Kelas Resiko : B
HISCL™ TSH Assay Kit
Analysis ID: AKL 20101612895

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

Jun 23, 2023

Expiry Date

Jan 16, 2028

Product Type

Clinical Chemistry Test System

Thyroid stimulating hormone test system (kit & cair)

Invitro Diagnostics

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