IMMUCOR Medizinische Diagnostik GmbH
Germany DE-MF-000006494 Last updated 21 Oct 2026
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- Devices
- 89
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
immuClone (1) Anti-C IgM Ref 0007206
immuClone® (2) Anti-e IgM Ref 0007507
immuClone (1) Anti-E IgM Ref 0007416
immuClone (2) Anti-c IgM Ref 0007307
immuClone® (1) Anti-e IgM Ref 0007516
immuClone (2) Anti-K IgM Ref 0008014
immuClone (1) Anti-E IgM Ref 0007406
immuClone® (2) Anti-C Galileo IgM Ref 0066012
immuClone® (2) Anti-C IgM Ref 0007205
immuClone Anti-P(1) IgM Ref 0008150
immuClone Anti-CDE IgM + IgG Ref 0006821
immuClone Anti-N Automated IgM Ref 0066022
immuClone (2) Anti-E Galileo IgM Ref 0066016
immuClone® (2) Anti-e IgM Ref 0007515
immuClone® (2) Anti-C IgM Ref 0007207
immuClone Anti-Cw IgM Ref 0007603
immuClone® (1) Anti-e IgM Ref 0007516
immuClone (1) Anti-c IgM Ref 0007306
immuClone (2) Anti-K Automated IgM Ref 0066038
immuClone® Anti-A, B IgM Ref 0066082
immuClone® Rh-Hr Control Galileo Ref 0066083
immuClone® (2) Anti-C IgM Ref 0007217
immuClone® Anti-D rapid Galileo IgM Ref 0066085
immuClone Anti-N IgM Ref 0009605
immuClone® Anti-D rapid IgM Ref 0007117
immuClone® (2) Anti-C IgM Ref 0007215
immuClone® (2) Anti-e IgM Ref 0007517
immuClone® Anti-B IgM Ref 0066002
immuClone (1) Anti-E Galileo IgM Ref 0066015
immuClone® (2) Anti-e IgM Ref 0007507
immuClone (1) Anti-K Galileo IgM Ref 0066020
immuClone Anti-s IgM Ref 0009959
immuClone® Anti-D fast IgM Ref 0007116
immuClone (2) Anti-E IgM Ref 0007417
immuClone® Anti-A IgM Ref 0066001
immuClone Anti-M Ref 0009506
immuClone (1) Anti-C IgM Ref 0007206
immuClone Anti-Cw IgM Galileo Ref 0066019
immuClone Anti-CDE Galileo IgM + IgG Ref 0066010
immuClone (1) Anti-C IgM Ref 0007216
immuClone (2) Anti-c Galileo IgM Ref 0066014
immuClone® (2) Anti-e Galileo IgM Ref 0066018
immuClone Anti-S IgM Ref 0009905
immuClone (2) Anti-E IgM Ref 0007407
immuClone (1) Anti-E IgM Ref 0007404
Galileo System Liquid Concentrate Ref 0066056
immuClone® (1) Anti-e Galileo IgM Ref 0066017
immuClone Anti-CDE IgM + IgG Ref 0006820
Anti-A1 Lectin Galileo Ref 0066004
immuClone® Rh-Hr Control IgM Ref 0006721
Showing 1-50 of 89
EUDAMED certificates
TÜV Rheinland LGA Products GmbH 0197 21 certificates
- HX 1191616-1 Reissued
Quality management system EU IVDR
- Issued
- 15 Sep 2026
- Expires
- 25 Oct 2031
- Valid from
- 26 Oct 2026
- IX 1191616-14 Supplemented
Technical documentation EU IVDR
- Issued
- 14 Apr 2026
- Expires
- 5 Dec 2028
- Reason
- Other
- IX 1191616-15 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 5 Dec 2028
- Reason
- Other
- IX 1191616-4 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 5 Dec 2028
- Reason
- Other
- IX 1191616-10 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 3 Dec 2028
- Reason
- Other
- IX 1191616-9 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 3 Dec 2028
- Reason
- Other
- IX 1191616-13 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 28 Nov 2028
- Reason
- Other
- IX 1191616-8 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 28 Nov 2028
- Reason
- Other
- IX 1191616-5 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 27 Nov 2028
- Reason
- Other
- IX 1191616-1 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 21 Nov 2028
- Reason
- Other
- IX 1191616-12 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 21 Nov 2028
- Reason
- Other
- IX 1191616-17 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 9 Nov 2028
- Reason
- Other
- IX 1191616-18 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 9 Nov 2028
- Reason
- Other
- IX 1191616-19 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 9 Nov 2028
- Reason
- Other
- IX 1191616-16 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 29 Oct 2028
- Reason
- Other
- IX 1191616-7 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 24 Oct 2028
- Reason
- Other
- IX 1191616-3 Supplemented
Technical documentation EU IVDR
- Issued
- 14 Apr 2026
- Expires
- 27 Sep 2028
- Reason
- Other
- IX 1191616-6 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 27 Sep 2028
- Reason
- Other
- IX 1191616-2 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 12 Sep 2028
- Reason
- Other
- HX 1191616-1 Supplemented
Quality management system EU IVDR
- Issued
- 10 Nov 2023
- Expires
- 25 May 2028
- Reason
- Add device or group
- IX 1191616-11 Supplemented
Technical documentation EU IVDR
- Issued
- 9 Apr 2026
- Expires
- 24 May 2028
- Reason
- Other
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Notified bodies
About
We are dedicated to offering products that enable patients in need of blood or an organ to receive the right match that is safe, accessible, and affordable.
What IMMUCOR Medizinische Diagnostik GmbH makes
IMMUCOR Medizinische Diagnostik GmbH produces in-vitro diagnostic (IVD) reagents for blood typing and antibody detection, including IgM-specific tests for antigens such as Anti-K, Anti-E, Anti-C, Anti-P(1), Anti-N, and Anti-Cw. Their portfolio also includes automated and manual systems for Rh-Hr control and ABO blood group identification, designed for compatibility testing in transfusion and transplantation settings.
The company’s diagnostic products fall under EU IVD device classes A, C, and D, reflecting varying levels of risk, and are registered in the EU’s eudamed database. The manufacturer is based in Germany and adheres to regulatory requirements for IVDs within the European Union.
Information
- Country
- Germany
- Address
- 32, Robert-Bosch-Straße, Dreieich, Germany
- Website
- www.immucor.com
- facebook.com/immucor
- [email protected]
- Phone
- +49 6103 8056 0
- PRRC contact
- Holger Kost
- EUDAMED SRN
- DE-MF-000006494