Certificate 041-00-00-MDR

Certificate number

041-00-00-MDR

Certificate type

Quality management system

Certificate status

Withdrawn

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Version

2

Certificate ID

0426041-00-00-MDR00

Issued

Feb 15, 2024

Valid from

Feb 15, 2024

Valid until

Feb 14, 2029

Manufacturer

Chiesi Farmaceutici S.p.A.

Manufacturer SRN

IT-MF-000030997

Manufacturer country

Italy

Notified body

ITALCERT SRL

Notified body SRN

0426

Notified body country

Italy

No specific devices are listed for this certificate.

Sterile

Yes

Human tissues

No

Animal tissues

No

In vitro diagnostics

No

Initial registration

No

New device

No

Discard allowed

No

SSCP enabled

Yes

Mechanism of scrutiny

No

Intended medical purpose

No

SPP applicable

No

Conditions applicable

No

MOS outside EUDAMED

—

QMS/MOS type

Class IIb only