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BIOSYNEX AMPLIQUICK Lysis - Indonesia BPOM Medical Device Registration

BIOSYNEX AMPLIQUICK Lysis is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208220387. The device is manufactured by BIOSYNEX Ltd. from France, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PACIFIC SAINTIFINDO.

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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Risk Class Kelas Resiko : B
BIOSYNEX AMPLIQUICK Lysis
Analysis ID: AKL 20208220387

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIOSYNEX Ltd.

Country of Origin

France

Authorized Representative

PT. PACIFIC SAINTIFINDO

AR Address

PASIFIK SAINTIFINDO

Registration Date

Dec 27, 2022

Expiry Date

Sep 06, 2024

Product Type

Hematological Reagents

Red cell lysing reagent.

Invitro Diagnostics

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