ELITECH Elitrol I - Indonesia BPOM Medical Device Registration
ELITECH Elitrol I is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101914951. The device is manufactured by ELITECH CLINICAL SYSTEMS SAS. from France, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MRK DIAGNOSTICS.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ELITECH CLINICAL SYSTEMS SAS.Country of Origin
France
Authorized Representative
PT. MRK DIAGNOSTICSAR Address
JL. Merpati Mas I Blok B1 NO.46 Perkantoran Tanjung Mas Raya Tanjung Barat
Registration Date
Sep 09, 2022
Expiry Date
Feb 05, 2026
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
ELITECH System Solution
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ELITECH CRP IP CONTROL II
ELITECH Total Protein Plus
ELITECH CK-MB Control
MAX 9k Multi Array Xplorer
MACROARRAY DIAGNOSTICS (MADX)
ALEXยฒ Allergy Xplorer
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FOOD DETECTIVEโข Professional
OMEGA DIAGNOSTICS LTD
FOODPRINT Microarray 200 + Food IgG ELISA
OMEGA DIAGNOSTICS LTD
BOULE Cleaning Kit
BOULE MEDICAL AB
BLUEDOT ANA + DFS-70 IgG
D-TEK SA.
BLUEDIVER Quantrix Liver 10 IgG
D-TEK SA.
MEDI-TEST Control N & P
MACHEREY NAGEL GMBH & CO., KG.
BLUEDIVER DOT ANA+DFS-70 IgG
D-TEK SA.
BLUEDIVER Instrument
D-TEK SA

