ELITECH System Solution - Indonesia BPOM Medical Device Registration
ELITECH System Solution is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204220269. The device is manufactured by ELITECH CLINICAL SYSTEMS SAS. from France, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is MRK DIAGNOSTICS.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
ELITECH CLINICAL SYSTEMS SAS.Country of Origin
France
Authorized Representative
MRK DIAGNOSTICSAR Address
JL. Merpati Mas I Blok B1 NO.46 Perkantoran Tanjung Mas Raya Tanjung Barat
Registration Date
Sep 28, 2022
Expiry Date
Feb 09, 2026
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
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ELITECH Elitrol I
ELITECH Creatinine Jaffe
ELITECH CRP IP CONTROL I
ELITECH Rheumatology Control II
ELITECH Phosporus
ELITECH CRP IP CONTROL II
ELITECH Total Protein Plus
ELITECH CK-MB Control
CERTEST H. pylori
CERTEST BIOTEC S.L.
ImageXplorer
MACROARRAY DIAGNOSTICS (MADX)
BlueDiver Quantrix ANA 25 Screen IgG
D-TEK SA.
BOULE Medonic M-series Diluent
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MEDONIC M51-D Diluent
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BOULE Medonic M-series Lyse
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MEDONIC M51-L2 Bright
BOULE MEDICAL AB
MEDONIC M51-L1 Lyse
BOULE MEDICAL AB
URYXXON Relax
MACHEREY NAGEL GMBH & CO., KG.
BOULE Medonic M-Series Dualpack, RFID
BOULE MEDICAL.