HIGHTOP Lyse II - Indonesia BPOM Medical Device Registration
HIGHTOP Lyse II is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208320721. The device is manufactured by QINGDAO HIGHTOP BIOTECH CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GRACE REMAINS PROSPEROUS.
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
QINGDAO HIGHTOP BIOTECH CO., LTDCountry of Origin
China
Authorized Representative
PT. GRACE REMAINS PROSPEROUSAR Address
ANUGERAH TETAP MAKMUR
Registration Date
Sep 07, 2023
Expiry Date
May 20, 2028
Product Type
Hematological Reagents
Red cell lysing reagent.
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