Statistics for ASPIVIX SA

1Total Devices

1Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for ASPIVIX SA

No certificates registered for this manufacturer.

Showing 1–1 of 1 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
P03-001-001-A1	`P03-001-001-A1`	`07649995423079`	1	On the market

Devices placed in 1 country

EUDAMED update: Mar 5, 2024

CH-MF-000026572

Active

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
SRN: BE-CA-007
Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

RINALDI Mauro
Ensure a quality management system (QMS) for regulatory purposes is implemented and maintained. Check the devices' conformity per the company's QMS before the device is released. Ensure that technical documentation and the EU documentation of conformity are generated and up-to-date. Ensure the company complies with post-market surveillance obligations listed in Article 10(10) of MDR. Ensure the company fulfils the reporting obligations in Articles 87-91 of MDR.
Hidden
FINCI Julien
Ensure that technical documentation and the EU documentation of conformity are generated and up-to-date. Ensure the company complies with post-market surveillance obligations listed in Article 10(10) of MDR. Ensure the company fulfils the reporting obligations in Articles 87-91 of MDR.
Hidden