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HISCL PSA Assay Kit - Indonesia BPOM Medical Device Registration

HISCL PSA Assay Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306510682. The device is manufactured by PRICES LABORATORIES, INC. from Japan, and is classified as Risk Class Kelas Resiko : C. 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 : C
HISCL PSA Assay Kit
Analysis ID: AKL 20306510682

Risk Classification

Kelas Resiko : C

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 20, 2021

Expiry Date

Jan 27, 2026

Product Type

Tumor Antigen Immunologic Test System

Tumor-associated antigen immunological test system.

Invitro Diagnostics

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DJ Fang

DJ Fang

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