ABL90 FLEX Solution Pack - Indonesia BPOM Medical Device Registration
ABL90 FLEX Solution Pack is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421996. The device is manufactured by RADIOMETER MEDICAL APS from Denmark, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
RADIOMETER MEDICAL APSCountry of Origin
Denmark
Authorized Representative
PT. ANDAMAN MEDICAL INDONESIAAR Address
Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma
Registration Date
Oct 08, 2024
Expiry Date
Jun 19, 2029
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
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