DrAccu LH FIA - Indonesia BPOM Medical Device Registration
DrAccu LH FIA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421252. The device is manufactured by ASSURE TECH. (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PROSPEROUS BIOCARE.
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
ASSURE TECH. (HANGZHOU) CO., LTD.Country of Origin
China
Authorized Representative
PROSPEROUS BIOCAREAR Address
RUKO KRANGGAN PERMAI BLOK RT 017/30
Registration Date
Jun 28, 2024
Expiry Date
Nov 22, 2028
Product Type
Clinical Chemistry Test System
Luteinizing hormone test system (card)
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