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Ravimiamet · 20. veebruar 2025
Viit
MSO-1/841-1
Registreeritud
20. veebruar 2025
Dokumendi liik
Sissetulev kiri
Adressaat
Malta Medicines Authority
Saabumis/saatmisviis
e-post
Funktsioon
MSO Meditsiiniseadmed
Sari
MSO-1 Eesti ja Euroopa Liidu ametiasutuste vaheline meditsiiniseadmetega seotud kirjavahetus
Toimik
MSO-1/2025
Vastutaja
Maarika Ojala (RA, Meditsiiniseadmete osakond)

Failid

Sisu (failidest)

Saatja: Gatt Baldacchino Elaine at Medicines Authority <[email protected]> Saaja: Grech Louise 1 at Medicines Authority, Farrugia Karen at Medicines Authority, Medical Devices at Medicines Authority Teema: MDR Article 59 Derogation for Androcor NV Dear Colleagues, We have received an application for a MDR Article 59 Derogation for Arterial Cannulae Reinforced, Aortic Catheter, Flex Line Venous Catheter and Flex Line Two Stage Venous Catheter manufactured by Andocor NV, Belgium. The rationale for the application is supply shortages and lack of alternatives. May you kindly indicate whether you use alternatives for the above mentioned medical devices and what these alternatives are? Thank you and kind regards, Elaine
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