Statistics for EUROMI

4Total Devices

3Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

2Countries

Certificate health for EUROMI

No certificates registered for this manufacturer.

Showing 1–4 of 4 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
1316INFL-2.5150	`1316INFL-2.5150`	`03701416200745`	1	On the market
1220LSU1B-3200	`1220LSU1B-3200`	`03701416203883`	1	On the market
1118NLF2DH	`1118NLF2DH`	`03701416203555`	1	On the market
1127ADIPC	`1127ADIPC`	`03701416203425`	1	On the market

Devices placed in 2 countries

EUDAMED update: Feb 13, 2024

BE-MF-000014212

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

BENOIT Perrine
- Ensure that 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. - Ensure that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
Hidden
MASCREZ Olivia
- Ensure that conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before release - Ensure that the technical documentation & EU DoC are drawn up & up-to-date - Ensure that PMS obligations are complied with (Article 10) - Ensure that reporting obligations referred to in Art 87 to 91 are fulfilled - Ensure that in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued
Hidden