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Danmark - Reparation og vedligeholdelse af medicinsk udstyr - Genbehandling af medicinsk engangsudstyr

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Description

Anskaffelsen vedrører genbehandling af medicinsk engangsudstyr med henblik på efterfølgende anvendelse i klinisk drift. Ydelsen omfatter indsamling, genbehandling, kvalitetskontrol, dokumentation, sporbarhed og returnering af det genbehandlede udstyr i overensstemmelse med gældende lovgivning. Dette sker i overensstemmelse med Europa-Parlamentets og Rådets forordning (EU) 2017/745 om medicinsk udstyr (MDR), artikel 17, stk. 2, hvorefter en juridisk eller fysisk person, der genbehandler medicinsk engangsudstyr med henblik på yderligere anvendelse, anses som fabrikant af det genbehandlede udstyr og skal opfylde de krav, der gælder for fabrikanter efter MDR.

Official source

Source: TED - Tenders Electronic Daily (Publications Office of the EU)

Always verify details on the official notice.

Last verified against TED - Tenders Electronic Daily (Publications Office of the EU) 1 month ago

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Avg. open tender · Repair & maintenance services
€8,810,734
5,723 open across Europe right now
Buyer track record on Aperlena
129 notices tracked · 67 awarded
€203,449,435 in awarded contracts

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