HELENA AGGRAM Advanced Modular System and Accessories - Indonesia BPOM Medical Device Registration
HELENA AGGRAM Advanced Modular System and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205602454. The device is manufactured by HELENA LABORATORIES. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ABADINUSA USAHASEMESTA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
HELENA LABORATORIES.Country of Origin
United States
Authorized Representative
PT. ABADINUSA USAHASEMESTAAR Address
Jalan Raden Saleh No. 45 G
Registration Date
Dec 19, 2023
Expiry Date
Dec 31, 2025
Product Type
Automatic and Semi-Automatic Hematology Equipment
Automated platelet aggregation system.
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