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HEALGEN Coronavirus Ag Rapid Test Cassette (Swab) - Indonesia BPOM Medical Device Registration

HEALGEN Coronavirus Ag Rapid Test Cassette (Swab) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303026076. The device is manufactured by ZHEJIANG ORIENT GENE BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is BINTANG MONO 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
HEALGEN Coronavirus Ag Rapid Test Cassette (Swab)
Analysis ID: AKL 20303026076

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

BINTANG MONO INDONESIA

AR Address

Perum Mahkota Simprug Blok A13 No. 9

Registration Date

Aug 18, 2021

Expiry Date

Sep 22, 2024

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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DJ Fang

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