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WEMED Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device) - Indonesia BPOM Medical Device Registration

WEMED Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305220506. The device is manufactured by BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. WEGO MEDIKA 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 : D
WEMED Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device)
Analysis ID: AKL 30305220506

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

China

Authorized Representative

PT. WEGO MEDIKA INDONESIA

AR Address

Jl. Tanah Abang II No.67 Kel. Petojo Selatan, Kec. Gambir, Jakarta Pusat

Registration Date

Nov 01, 2022

Expiry Date

Oct 31, 2025

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

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DJ Fang

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