SERENITY HCG Pregnancy Test (Midstream) - Indonesia BPOM Medical Device Registration
SERENITY HCG Pregnancy Test (Midstream) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101611147. The device is manufactured by CORE TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SERENITY 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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
CORE TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. SERENITY INDONESIAAR Address
Komplek Ruko Permata Kota Blok Q No. 10 Jl. Pangeran Tubagus Angke No.170 RT.010 RW . 01
Registration Date
Jul 06, 2023
Expiry Date
Feb 07, 2028
Product Type
Clinical Chemistry Test System
Human chorionic gonadotropin (HCG) test system (strip & midstream)
Invitro Diagnostics
FLAGSHIP Personal Pregnancy Test Kit
ANDALAN Ovulation Test
FLAGSHIP Personal Pregnancy Test Kit
SERENITY HCG Pregnancy Test (Strip)
FEMITIA SENSIPACK Personal Pregnancy Test Cassette
Coretests HBsAg Test
Coretests HCV Test
Coretests TP Syphilis Test
FEMITIA SensiPlan
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