STAT PROFILE pHOx Plus Advanced Technology Blood Gas Analyzer and Accessories - Indonesia BPOM Medical Device Registration
STAT PROFILE pHOx Plus Advanced Technology Blood Gas Analyzer and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101510062. The device is manufactured by NOVA BIOMEDICAL CORPORATION. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. TAMARA OVERSEAS CORPORINDO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
NOVA BIOMEDICAL CORPORATION.Country of Origin
United States
Authorized Representative
PT. TAMARA OVERSEAS CORPORINDOAR Address
Jl. Pinangsia Timur No. 49 Jakarta 11110
Registration Date
Oct 27, 2022
Expiry Date
Feb 09, 2027
Product Type
Clinical Chemistry Test System
Blood gases (P CO 2, P O 2) and blood pH test system
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