DIASYSTEM Unilab N - Indonesia BPOM Medical Device Registration
DIASYSTEM Unilab N is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324109. The device is manufactured by DIASYSTEM SCANDINAVIA AB from Sweden, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DUAL NOBLE LIGHT.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
DIASYSTEM SCANDINAVIA ABCountry of Origin
Sweden
Authorized Representative
PT. DUAL NOBLE LIGHTAR Address
Ruko Villa Jatibening Toll Blok A no. 2 Jatibening - Bekasi
Registration Date
Oct 16, 2023
Expiry Date
May 25, 2027
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
DIASYSTEM Bilirubin (Total)
DIASYSTEM Album (BCG)
DIASYSTEM Bilirubin (Direct)
DIASYSTEM Creatinine Jaffe
DIASYSTEM Uric Acid (TBHBA)
DIASYSTEM Urea (UV)
DIASYSTEM Cholesterol (Total)
DIASYSTEM Glucose (GOD)
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