HEMAX CellLyse Lyse-HX3 - Indonesia BPOM Medical Device Registration
HEMAX CellLyse Lyse-HX3 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208912167. The device is manufactured by B&E BIO-TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. WHIRA PITOE USAHABERSAMA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
B&E BIO-TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. WHIRA PITOE USAHABERSAMAAR Address
RUKO BUARAN PERSADA NO. 10, JL. JEND.POL.SOEKAMTO RT.008/06,KEL.DUREN SAWIT
Registration Date
Sep 05, 2022
Expiry Date
May 12, 2027
Product Type
Hematological Reagents
Red cell lysing reagent.
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