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KY-BIO COVID-19 Ag Test - Indonesia BPOM Medical Device Registration

KY-BIO COVID-19 Ag Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303122131. The device is manufactured by ZHEJIANG KUAYE BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. RAJAERBA INDOCHEM.

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
KY-BIO COVID-19 Ag Test
Analysis ID: AKL 20303122131

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. RAJAERBA INDOCHEM

AR Address

GEDUNG PEMBINA GRAHA JL. DI. PANJAITAN NO.45 RAWA BUNGA

Registration Date

Mar 30, 2022

Expiry Date

Nov 20, 2025

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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