Certificate IX 1191616-8

Certificate number

IX 1191616-8

Certificate type

Technical documentation

Certificate status

Issued

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Version

1

Certificate ID

0197IX 1191616-8Rev. 0

Issued

Nov 29, 2023

Valid from

Nov 29, 2023

Valid until

Nov 28, 2028

Manufacturer

IMMUCOR Medizinische Diagnostik GmbH

Manufacturer SRN

DE-MF-000006494

Manufacturer country

Germany

Notified body

TÜV Rheinland LGA Products GmbH

Notified body SRN

0197

Notified body country

Germany

• immuClone (2) Anti-E IgM and GalileoIVDR Class D
  88823405W0103030202D29JR

Sterile

—

Human tissues

—

Animal tissues

—

In vitro diagnostics

—

Initial registration

Yes

New device

No

Discard allowed

No

SSCP enabled

Yes

Mechanism of scrutiny

Yes

Intended medical purpose

—

SPP applicable

—

Conditions applicable

No

MOS outside EUDAMED

—

QMS/MOS type

Others

No status changes or preceding certificates are recorded.