IMMUCOR Medizinische Diagnostik GmbH

Certificate IX 1191616-12

Rev. Rev. 0Issued

Valid until: Nov 21, 2028

Certificate IX 1191616-12 is a valid Technical documentation issued to IMMUCOR Medizinische Diagnostik GmbH and registered in EUDAMED. Valid until November 21, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: IX 1191616-12
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 1191616-12Rev. 0

Validity

Issued: Nov 22, 2023
Valid from: Nov 22, 2023
Valid until: Nov 21, 2028

Manufacturer

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
Manufacturer country: Germany

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

immuClone (1) Anti-K IgM and GalileoIVDR Class D
88823405W0103030501D26KK

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

immuClone (1) Anti-K IgM and Galileo
88823405W0103030501D26KK

Documents

LanguagesEN