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NORMA-iLyse3 - Indonesia BPOM Medical Device Registration

NORMA-iLyse3 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208220031. The device is manufactured by NORMA DIAGNOSTIKA GMBH. from Austria, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. 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.

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BPOM Registered
Risk Class Kelas Resiko : B
NORMA-iLyse3
Analysis ID: AKL 20208220031

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Austria

Authorized Representative

PT. RAFA TOPAZ MAIN

AR Address

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

Registration Date

Jan 31, 2022

Expiry Date

Oct 28, 2026

Product Type

Hematological Reagents

Red cell lysing reagent.

Invitro Diagnostics

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