Pure Global

FOCCUS HCG One Step Pregnancy Strip Test - Indonesia BPOM Medical Device Registration

FOCCUS HCG One Step Pregnancy Strip Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324059. 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 PT. ALKESMED MAIN PARTNERS.

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
FOCCUS HCG One Step Pregnancy Strip Test
Analysis ID: AKL 20101324059

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. ALKESMED MAIN PARTNERS

AR Address

Ruko Malangsari Kav. 2A Jl. Malangsari Raya

Registration Date

Oct 09, 2023

Expiry Date

Oct 07, 2026

Product Type

Clinical Chemistry Test System

Human chorionic gonadotropin (HCG) test system

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from ZHEJIANG ORIENT GENE BIOTECH CO.,LTD
Products from the same manufacturer (3 products)