I-SENS i-Smart Electrolyte Quality Control (Ca2+) - Indonesia BPOM Medical Device Registration
I-SENS i-Smart Electrolyte Quality Control (Ca2+) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421855. The device is manufactured by I-SENS from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is DUAL NOBLE LIGHT.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
I-SENSCountry of Origin
Korea
Authorized Representative
DUAL NOBLE LIGHTAR Address
Ruko Villa Jatibening Toll Blok A no. 2 Jatibening - Bekasi
Registration Date
Sep 23, 2024
Expiry Date
Apr 05, 2028
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
GIESSE Hematology Analyzer Lyse 2 GS5
GIESSE DIAGNOSTICS.
I-SMART QC Blood Gas Electrolyte Metabolite Quality Control Multi Level
I-SENS, INC.
DIASYSTEM Bilirubin (Total)
DIASYSTEM SCANDINAVIA AB
DIASYSTEM Creatinine Jaffe
DIASYSTEM SCANDINAVIA AB
DIASYSTEM Uric Acid (TBHBA)
DIASYSTEM SCANDINAVIA AB
DIASYSTEM Urea (UV)
DIASYSTEM SCANDINAVIA AB
Giesse_Hematology Analyzer Diluent GS3
GIESSE DIAGNOSTICS.

