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Ravimiamet
FOR VISUALLY IMPAIRED

Medical device

EMDDB code 20858
Basic UDI-DI 8437013457Promonitor004GV
Seadme klass In vitro diagnostikameditsiiniseade
Medical Device Nomenclature
Risk class Class B
Appliance -
Device name (in Estonian) Promonitor-ANTI-ADL
Device name (in English) Promonitor-ANTI-ADL
Intended use (is Estonian) Promonitor-ANTI-ADL on ensüümiga seotud immunosorbentanalüüs adalimumabi vastaste antikehade kvantitatiivseks tuvastamiseks inimese seerumis.
Intended use (in English) Promonitor-ANTI-ADL is an enzyme-linked immunosorbent assay for the quantitative detection of anti-adalimumab antibodies in human serum.
Type/model/article number 5090230000
Notified body 0123
Manufacturer Progenika Biopharma, S.A.
In register from 07/29/2024
Entry status Active
Reimbursed by EHIF Tervisekassa soodustus puudub
Distribution
ID No. Distributors name Distributors code From

Piksel

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