Pure Global

CARESTART™ Malaria HRP2/pLDH (Pf/PAN) Combo - Indonesia BPOM Medical Device Registration

CARESTART™ Malaria HRP2/pLDH (Pf/PAN) Combo is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303013744. The device is manufactured by ACCESS BIO INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INDOCORE PERKASA.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
CARESTART™ Malaria HRP2/pLDH (Pf/PAN) Combo
Analysis ID: AKL 20303013744

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ACCESS BIO INC.

Country of Origin

United States

Authorized Representative

PT. INDOCORE PERKASA

AR Address

Komplek Graha Mas Pemuda Blok AB No. 19, Jl. Pemuda RT 020 / RW 006 Kel. Jati, Kec. Pulo Gadung, Jakarta Timur, DKI Jakarta

Registration Date

Sep 17, 2019

Expiry Date

Aug 07, 2024

Product Type

Serological Reagents

Plasmodium species antigen detection assays

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Similar Products (1)
Other products with the same name