Statistics for 3D-Shaper Medical

3Total Devices

1Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for 3D-Shaper Medical

No certificates registered for this manufacturer.

Showing 1–3 of 3 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
3D-SHAPER	`3D-SHAPER ver 2.13`	`08437021740035`	1	On the market
3D-SHAPER	`3D-SHAPER`	`08437021740011`	1	On the market
3D-SHAPER Ver.2.14	`3D-SHAPER`	`08437021740059`	1	On the market

Devices placed in 1 country

EUDAMED update: Nov 22, 2023

ES-MF-000001324

Active

HUMBERT Ludovic
As substitute PRRC, he is responsible of performing the actions of the PRRC when the PRRC is not available.
Hidden
IZQUIERDO María
-Verification of the conformity of the manufactured devices in accordance with the quality management system before a device is released; -the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. -the post-market surveillance obligations are complied with in accordance with MDR. -the reporting obligations referred to Vigilance are fulfilled. -in case of investigational devices, the statement referred to in MDR is issued.
Hidden