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HEALTH MATE Malaria Pf/Pan (HRP-II) - Indonesia BPOM Medical Device Registration

HEALTH MATE Malaria Pf/Pan (HRP-II) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303023161. The device is manufactured by DFI CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. RAJAWALI NUSINDO.

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
HEALTH MATE Malaria Pf/Pan (HRP-II)
Analysis ID: AKL 20303023161

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

DFI CO., LTD.

Country of Origin

Korea

Authorized Representative

PT. RAJAWALI NUSINDO

AR Address

Gedung RNI Jl. Denpasar Raya Kav DIII Kuningan Jakarta Selatan

Registration Date

Jun 09, 2020

Expiry Date

Jan 14, 2024

Product Type

Serological Reagents

Plasmodium species antigen detection assays

Invitro Diagnostics

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