Pure Global

GUARDIAN Pregnancy Test Strip - Indonesia BPOM Medical Device Registration

GUARDIAN Pregnancy Test Strip is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324062. The device is manufactured by AMERITECH DIAGNOSTIC REAGENT (JIAXING) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DISTRIBUTION OF HEALTH AND BEAUTY OF THE ARCHIPELAGO.

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
GUARDIAN Pregnancy Test Strip
Analysis ID: AKL 20101324062

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

AR Address

Graha HERO, CBD Bintaro Sektor 7, B.7/A.7

Registration Date

Oct 09, 2023

Expiry Date

Feb 14, 2028

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 AMERITECH DIAGNOSTIC REAGENT (JIAXING) CO., LTD.
Products from the same manufacturer (2 products)