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GUARDIAN One Step Pregnancy Test - Indonesia BPOM Medical Device Registration

GUARDIAN One Step Pregnancy Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323998. 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.

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BPOM Registered
Risk Class Kelas Resiko : B
GUARDIAN One Step Pregnancy Test
Analysis ID: AKL 20101323998

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 04, 2023

Expiry Date

Feb 14, 2028

Product Type

Clinical Chemistry Test System

Human chorionic gonadotropin (HCG) test system

Invitro Diagnostics

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