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 (2) Anti-c IgM Ref 0007317
immuClone (1) Anti-c IgM Ref 0007316
immuClone (1) Anti-c IgM Ref 0007304
immuClone® (1) Anti-e IgM Ref 0007514
immuClone (2) Anti-E IgM Ref 0007405
immuClone Anti-H Galileo IgM Ref 0066005
Anti-A1 Lectin Ref 0005405
immuClone® Anti-B IgM Ref 0066081
immuClone (1) Anti-C Galileo IgM Ref 0066011
immuClone® (2) Anti-e IgM Ref 0007505
immuClone Anti-H IgM Ref 0009525
immuClone® (1) Anti-e IgM Ref 0007506
Galileo NEO Ref 0064600
Galileo Diluent Ref 0066058
immuClone (1) Anti-c IgM Ref 0007314
Anti-K (Kell) quick Ref 0008050
Galileo Diluent Ref 0066055
Anti-Wr(a) Ref 0099120
immuClone (2) Anti-c IgM Ref 0007307
immuClone Anti-D duo IgM + IgG Ref 0006199
immuClone (1) Anti-C IgM Ref 0007214
immuClone (1) Anti-K IgM Ref 0008016
NEO Iris Ref 0064598
immuClone (2) Anti-c IgM Ref 0007315
Anti-A hel Ref 0005602
immuClone® (1) Anti-e IgM Ref 0007504
immuClone® Anti-D fast IgM Ref 0007126
immuClone® Anti-D rapid Galileo IgM Ref 0066008
immuClone (1) Anti-C IgM Ref 0007204
immuClone Anti-M Galileo Ref 0066021
immuClone (1) Anti-c Galileo IgM Ref 0066013
immuClone® Rh-Hr Control Galileo Ref 0066006
immuClone® Anti-D rapid IgM Ref 0007127
immuClone® Anti-A, B IgM Ref 0066003
Showing 51-84 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