Pure Global

MONO FT4 (FREE Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories - Indonesia BPOM Medical Device Registration

MONO FT4 (FREE Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323587. The device is manufactured by AEHEALTH LIMITED from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
MONO FT4 (FREE Thyroxine) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories
Analysis ID: AKL 20101323587

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

AEHEALTH LIMITED

Country of Origin

United Kingdom

Authorized Representative

PT. BINTANG MONO INDONESIA

AR Address

Perum Mahkota Simprug Blok A13 No. 9

Registration Date

Aug 02, 2023

Expiry Date

Aug 01, 2026

Product Type

Clinical Chemistry Test System

Free thyroxine test system (card)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing