Statistics for Gelesis Srl

1Total Devices

1Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for Gelesis Srl

No certificates registered for this manufacturer.

Showing 1–1 of 1 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
MC0801-XX, MC0802-XX	`MC0801-XX, MC0802-XX`	`08055162880009`	1	On the market

Devices placed in 1 country

EUDAMED update: Jul 11, 2024

IT-MF-000027919

Active

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

MELCARNE Carla
(a) 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) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
Hidden
SORCINI Giorgio
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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