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QIAstat-Dx ® Analyzer 1.0 - Indonesia BPOM Medical Device Registration

QIAstat-Dx ® Analyzer 1.0 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102320614. 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 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 ® Analyzer 1.0
Analysis ID: AKL 20102320614

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

LRE MEDICAL GMBH

Country of Origin

Germany

Authorized Representative

UBC MEDICAL INDONESIA

AR Address

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

Registration Date

Aug 24, 2023

Expiry Date

Nov 08, 2027

Product Type

Clinical Laboratory Equipment

Instrumentation for clinical multiplex test systems.

Invitro Diagnostics

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