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03770008181496

Anti-Kell (clone MS-56)

IVD Annex II List AIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Institut de Biotechnologies Jacques Boy
Manufacturer SRN: FR-MF-000004609
UDI-DI: 03770008181496
Basic UDI-DI: B-03770008181496
Reference: 152250263
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:21

Manufacturer products View details

03770008181465

DAT-QC C3b-C3d

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Institut de Biotechnologies Jacques Boy
Manufacturer SRN: FR-MF-000004609
UDI-DI: 03770008181465
Basic UDI-DI: B-03770008181465
Reference: 97367
EMDN: W0103030401
EMDN description: COOMBS CONTROL CELLS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:21

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03770008181458

DAT-QC IgG

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Institut de Biotechnologies Jacques Boy
Manufacturer SRN: FR-MF-000004609
UDI-DI: 03770008181458
Basic UDI-DI: B-03770008181458
Reference: 97257
EMDN: W0103030401
EMDN description: COOMBS CONTROL CELLS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:21

Manufacturer products View details

03760369291187

RedQal

IVD Annex II List AIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN: FR-MF-000013221
UDI-DI: 03760369291187
Basic UDI-DI: B-03760369291187
Reference: 190045
EMDN: W0103030999
EMDN description: COMBINED ABO TYPING + RHESUS TYPING TEST - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:19

Manufacturer products View details

CQI ABO-D - Rh.K - Contrôle Qualité Interne pour la détermination des groupes sanguins dans les systèmes ABO Rhésus Kell (CB Grifols)

RedQal

IVD Annex II List AIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN: FR-MF-000013221
UDI-DI: 03760369291132
Basic UDI-DI: B-03760369291132
Reference: 242623
EMDN: W0103030999
EMDN description: COMBINED ABO TYPING + RHESUS TYPING TEST - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:19

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Anti-Jsb for card method monocolonal, IgG

Anti-Jsb for card method monocolonal, IgG - 01.244-02

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: D-01.244-02CZ
Basic UDI-DI: B-01.244-02CZ
Reference: 01.244-02
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 16:08

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Anti-P1 for card method monoclonal, human IgM clone: P3NIL100

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: D-01.243-03CU
Basic UDI-DI: B-01.243-03CU
Reference: 01.243-03
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 16:08

Manufacturer products View details

Anti-Leb for card method monoclonal, human clone: P3F234MD4

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: D-01.242-03CM
Basic UDI-DI: B-01.242-03CM
Reference: 01.242-03
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 16:08

Manufacturer products View details

DAY Neutral Gel

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330001819
Basic UDI-DI: 93543300030010L6
Reference: 30011-4
EMDN: W01030399
EMDN description: IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

DAY LISS Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330001802
Basic UDI-DI: 93543300310104LZ
Reference: 31010-4
EMDN: W0103030306
EMDN description: ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

DAY Bromelin Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330001345
Basic UDI-DI: 93543300320106MG
Reference: 32010-6
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

STARGEL10 STAR SOLUTION

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330000553
Basic UDI-DI: 93543300GT20118P
Reference: GT2011
EMDN: W0103030306
EMDN description: ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

STARGEL10 NEUTRAL

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330000263
Basic UDI-DI: 93543300GT20108M
Reference: GT2010-10
EMDN: W01030399
EMDN description: IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

STATUS1 Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330000058
Basic UDI-DI: 93543300TT1003DS
Reference: TT1003
EMDN: W0103030306
EMDN description: ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

immuClone® Anti-A,B IgM

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
UDI-DI: 10888234300847
Basic UDI-DI: 88823405W0103030102D33J3
Reference: 0066003
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Germany
Safety summary (SSCP/SSP): 05.PER.0253 · Rev. 002
Authorised representative: -
Last updated: 03.07.2026 21:09

Manufacturer products Open in EUDAMED View details

immuClone® Anti-B IgM

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
UDI-DI: 10888234300830
Basic UDI-DI: 88823405W0103030102D34J5
Reference: 0066002
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Germany
Safety summary (SSCP/SSP): 05.PER.0254 · Rev. 003
Authorised representative: -
Last updated: 03.07.2026 21:09

Manufacturer products Open in EUDAMED View details

immuClone® Anti-A IgM

IVD Class DIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
UDI-DI: 10888234300823
Basic UDI-DI: 88823405W0103030102D32HZ
Reference: 0066001
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Germany
Safety summary (SSCP/SSP): 05.PER.0252 · Rev. 003
Authorised representative: -
Last updated: 03.07.2026 21:09

Manufacturer products Open in EUDAMED View details

immuClone (1) Anti-K IgM

immuClone (1) Anti-K IgM and Galileo

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
UDI-DI: 10888234300625
Basic UDI-DI: 88823405W0103030501D26KK
Reference: 0008016
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Germany
Safety summary (SSCP/SSP): 05.PER.0246 · Rev. 005
Authorised representative: -
Last updated: 03.07.2026 21:09

Manufacturer products Open in EUDAMED View details

Anti-K (Kell) quick

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
UDI-DI: 10888234300618
Basic UDI-DI: 88823405W0103030501D15KE
Reference: 0008015
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Germany
Safety summary (SSCP/SSP): 05.PER.0240 · Rev. 003
Authorised representative: -
Last updated: 03.07.2026 21:09

Manufacturer products Open in EUDAMED View details

immuClone (2) Anti-K IgM

immuClone (2) Anti-K IgM and Automated

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
UDI-DI: 10888234300601
Basic UDI-DI: 88823405W0103030501D31KC
Reference: 0008014
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Germany
Safety summary (SSCP/SSP): 05.PER.0251 · Rev. 005
Authorised representative: -
Last updated: 03.07.2026 21:09

Manufacturer products Open in EUDAMED View details