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QIAstat-Dx Operational Module PRO - Indonesia BPOM Medical Device Registration

QIAstat-Dx Operational Module PRO is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102420358. The device is manufactured by LRE MEDICAL GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. UBC MEDICAL 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
QIAstat-Dx Operational Module PRO
Analysis ID: AKL 20102420358

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

LRE MEDICAL GMBH

Country of Origin

Germany

Authorized Representative

PT. UBC MEDICAL INDONESIA

AR Address

Jalan Rawa Gelam V, Blok L Kav. 11-13, Kawasan Industri Pulogadung Jakarta Timur13930

Registration Date

Oct 29, 2024

Expiry Date

May 13, 2028

Product Type

Clinical Laboratory Equipment

Instrumentation for clinical multiplex test systems.

Invitro Diagnostics

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