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QIAstat-Dx ME Panel - Indonesia BPOM Medical Device Registration

QIAstat-Dx ME Panel is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321262. The device is manufactured by STAT -DX LIFE S.L from Spain, and is classified as Risk Class Kelas Resiko : C. 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 : C
QIAstat-Dx ME Panel
Analysis ID: AKL 20303321262

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

STAT -DX LIFE S.L

Country of Origin

Spain

Authorized Representative

PT. UBC MEDICAL INDONESIA

AR Address

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

Registration Date

Jul 13, 2023

Expiry Date

Nov 08, 2027

Product Type

Serological Reagents

Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid

Invitro Diagnostics

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