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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
AMERITECH DIAGNOSTIC REAGENT (JIAXING) CO., LTD.Country of Origin
China
Authorized Representative
PT. DISTRIBUTION OF HEALTH AND BEAUTY OF THE ARCHIPELAGOAR 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
GUARDIAN Kids Cooling Gel Pad
FUSO TEIYAKU QINGDAO CO., LTD
GUARDIAN Cooling Gel Pad
FUSO TEIYAKU QINGDAO CO., LTD
GUARDIAN Dental Floss โ Waxed Mint
YANGZHOU STAR ORAL CARE PRODUCTS CO., LTD.
GUARDIAN Fabric Plasters
ASO PHILIPPINES, INC
GUARDIAN Pregnancy Test Strip
AMERITECH DIAGNOSTIC REAGENT (JIAXING) CO., LTD.
GUARDIAN Surgical Tape
QIDONG FARJOY MEDICAL MATERIAL CO., LTD.
GUARDIAN Plastic Plasters
ASO PHILIPPINES, INC
GUARDIAN Waterproof Plasters
WAYSON MEDICAL CO., LTD.
GUARDIAN Waterproof Cartoon Plasters
WAYSON MEDICAL CO., LTD.
GUARDIAN Kids Hello Kitty Light-up Junior Toothbrush
TWINKLERS LIMITED

