Haemonetics S.A.

SRN

CH-MF-000034549

Role

Manufacturer

Country

Switzerland

Organization name

Haemonetics S.A.

EU VAT number

CHE-107.970.845

Trade register

CHE-107.970.845

Date of registration

Mar 29, 2023

Address

6, RUE DE FLECHERES SIGNY CENTRE 1274 SIGNY-CENTRE SWITZERLAND

Email

regulatoryeurope@haemonetics.com

Name

Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico

SRN

IT-CA-070

Phone

+39 06 5994 3199/ +39 06 5994 3207

Email

segr.dgfdm@sanita.it

• RYAN Julie
  The technical documentation and the EU declaration of conformity in respect of the Devices are drawn up and kept up-to date; In the case of investigational devices (if any), the statement referred to in Section 4.1 of Chapter II of Annex XV of the MDR is issued; and In the case of devices for performance studies intended to be used in the context of interventional clinical performance studies, the statement referred to on section 4.1 of Chapter I of Annex XIV of the IVDR is issued.
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• KILLION Jim
  The conformity of the Devices is appropriately checked, in accordance with the quality management system under which the Devices are manufactured, before each Device is released; The post-market surveillance obligations related to the Devices are complied with in accordance with the Regulations; and The vigilance reporting obligations (as referred to in Articles 87 to 91 of the MDR and Articles 82 to 86 of the IVDR) are fulfilled in respect of the Devices
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No devices registered for this manufacturer.

Devices placed in 2 countries

• Italy26
• France3

No certificates registered for this manufacturer.