Certificate 0425-MDR-030086-00

Certificate number

0425-MDR-030086-00

Certificate type

Quality management system

Certificate status

Issued

Applicable legislation

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

Version

1

Certificate ID

04250425-MDR-030086-0000

Issued

Jul 17, 2024

Valid from

Jul 17, 2024

Valid until

Jul 16, 2029

Manufacturer

BIOAMPERE RESEARCH Srl

Manufacturer SRN

IT-MF-000029090

Manufacturer country

Italy

Notified body

ICIM S.P.A.

Notified body SRN

0425

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

Yes

New device

No

Discard allowed

No

SSCP enabled

Yes

Mechanism of scrutiny

Yes

Intended medical purpose

No

SPP applicable

No

Conditions applicable

No

MOS outside EUDAMED

—

QMS/MOS type

Class IIb only

No status changes or preceding certificates are recorded.