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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Immucor, Inc. — Manufacturer in United States

EUDAMED update: Jul 1, 2026

II

Immucor, Inc.

United States

All roles followed

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Sources: EUDAMED

Legal information of Immucor

Legal name: Immucor, Inc.
EU VAT number: Not applicable
EORI: See attached business license
Trade register: N/A
SRN (displayed role): US-MF-000011568
EUDAMED status: Active· registered in 2021
Registered office: Gateway Drive, 3130 30071 Norcross, United States

Contact details for Immucor

Phone: +1 770 441 2051
Email: regulatoryimmucor@werfen.com
Website: www.transfusionandtransplant.werfen.com
Address: 3130, GATEWAY DRIVE 30071 NORCROSS UNITED STATES

Data export

Export the 27 devices of Immucor

Get the catalogue in Excel or CSV format — trade name, product reference, UDI and EMDN codes, legislation, quantity, last update, and more. The exact row count and price are confirmed before you pay.

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32 columns included

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Medical device manufacturers in EUDAMED

Competent authority for Immucor

DE/CA23 - Regierungspräsidium Darmstadt Dezernat IV/Da 45.2
GermanyContact the authority →

Certificates of Immucor

27Total Devices

27Basic UDI-DIs

1Certificates1 valid · 0 expiring < 12 months

32CountriesEU/EEA placements

Market presence of Immucor

Devices placed in 32 countries

Risk categories of Immucor

Executives & regulatory representatives of Immucor

4 contacts identified

PRRC
PRRC
PRRC
THOMAS Charnelle
Checking device conformity before released. PMS obligations in Articles 10(9) & 78. Creating up-to-date technical documentation/EU DoC. Reporting obligations in Articles 82 to 86, including associated implementing acts of guidance adopted by MDCG. Issuing statement in Section 4.1 of Annex XIV for interventional clinical performance studies or other performance involving risks for the subjects.
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SCHIERTS Jennifer

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Cartography of Immucor

Authorised representativeNotified bodiesPeople

TÜV Rheinland LGA Products GmbH — 1 certificate — Immucor
IMMUCOR Medizinische Diagnostik GmbH — represents — Immucor
QUANDER Troy — Immucor
SCHIERTS Jennifer — Immucor
SMITH Brian — Immucor

Related documents of Immucor

Quality management system

Certificate HX 1804147-1Rev. Rev. 6

Supplemented

Manufacturer

Immucor, Inc.

Notified body

TÜV Rheinland LGA Products GmbH

0197

Version

7

Valid from

10/1/2025

Valid until

5/10/2028

Catalog of Immucor

27 devices · 27 families

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CMT Plates1 version
Red Blood Cell (RBC) Storage Solution1 version
Specimen Diluent1 version
ECHO Lumena1 version
Galileo Echo1 version
Platelet Wash and Storage Solution1 version
Anti-Lea (Murine Monoclonal) Gamma-clone1 version
Gamma P1 Blood Group Substance1 version
Automated C3d Plate1 version
Anti-Kpa1 version
Anti-Leb (Murine Monoclonal) Gamma-clone 1 version
Anti-k (Monoclonal) (IgG) Gamma-clone 1 version
Anti-Kpb Blood Grouping Reagent1 version
Gamma ELU-KIT II 1 version
Gamma EGA Kit1 version
H.P.C. (Human Platelet Concentrate)1 version
DAT Positive Control Cell1 version
RESt (Rabbit Erythrocyte Stroma)1 version
Gamma Lewis Blood Group Substance1 version
Complement Control Cells1 version
GammaZyme-B1 version
GammaZyme-F1 version
Freeze-Dried Papain1 version
W.A.R.M.(Warm Autoantibody Removal Medium)1 version
Anti-IgG,-C3d (Murine Monoclonal); Polyspecific, Gamma-clone1 version

27 families

Page 1 of 2

Browse all 27 products