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MAGLUMI HE4 (CLIA) - Indonesia BPOM Medical Device Registration

MAGLUMI HE4 (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306520001. The device is manufactured by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SNIBE DIAGNOSTIC INDONESIA.

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Risk Class Kelas Resiko : C
MAGLUMI HE4 (CLIA)
Analysis ID: AKL 20306520001

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. SNIBE DIAGNOSTIC INDONESIA

AR Address

TEMPO SCAN TOWER, LANTAI 21, JALAN H.R. RASUNA SAID KAV. 3-4

Registration Date

Jan 03, 2025

Expiry Date

Aug 13, 2029

Product Type

Tumor Antigen Immunologic Test System

Tumor-associated antigen immunological test system.

Invitro Diagnostics

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