PROHS Equipamento Hospitalar e Serviços Associados S.A.

Dispositifs placés dans 1 pays

• Portugal92

SRN

PT-MF-000002798

Rôle

Fabricant

Pays

Portugal

Nom de l'organisation

PROHS Equipamento Hospitalar e Serviços Associados S.A.

Numéro TVA UE

PT505005468

EORI

PT505005468

Date d'enregistrement

9 avr. 2021

Adresse

316, RUA DO CASTANHAL Z. INDUSTRIAL MAIA SECTOR II 4475-122 MAIA PORTUGAL

Téléphone

+351229059170

Email

prohs@prohs.pt

Site web

www.prohs.pt

Nom

INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.

SRN

PT-CA-013

Téléphone

+ 351 21 798 73 07

Email

daps@infarmed.pt

• SILVA Luísa
  a) Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; b) Ensure the post-market surveillance obligations are complied with in accordance with Article 10(10) of MDR; c) Ensure that reporting obligations referred to in Articles 87 to 91 of MDR are met for: • Serious incidents; • Field Safety Corrective Actions (FSCA) • Trend Reporting • Analysis of serious incidents • Analysis of FSCA • Analysis of vigilance data
  Masqué
• RODRIGUES Milton
  a) Ensure the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; b) Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
  Masqué

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