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43 device results listed.

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ImmuLINK®

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234001034
Basic UDI-DI: 88823401W0202030182A000TP
Reference: 0064319
EMDN: W0202030182
EMDN description: BLOOD GROUPING ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

H.P.C. (Human Platelet Concentrate)

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234001027
Basic UDI-DI: 88823401W01030399C030005L
Reference: 0057320
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

10888234001010

W.A.R.M.(Warm Autoantibody Removal Medium)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234001010
Basic UDI-DI: 88823401W0103030307C003TJ
Reference: W.A.R.M. (Warm Autoantibody Removal Medium)
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

RESt (Rabbit Erythrocyte Stroma)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234001003
Basic UDI-DI: 88823401W01030399C040005T
Reference: 0057316
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-Dried Papain

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000990
Basic UDI-DI: 88823401W0103030307C002TG
Reference: 0057292
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Complement Control Cells

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000914
Basic UDI-DI: 88823401W0103030401C200S5
Reference: 0007930
EMDN: W0103030401
EMDN description: COOMBS CONTROL CELLS
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Gamma EGA Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000877
Basic UDI-DI: 88823401W01030399C020025H
Reference: 0007865
EMDN: W0103030299
EMDN description: RHESUS TYPING ASSAYS OTHER
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Gamma ELU-KIT II

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000860
Basic UDI-DI: 88823401W01030399C020015F
Reference: 0007861
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Gamma Lewis Blood Group Substance

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000853
Basic UDI-DI: 88823401W01030399C0500062
Reference: 0007702
EMDN: W01030399
EMDN description: IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Gamma P1 Blood Group Substance

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000846
Basic UDI-DI: 88823401W01030399C0500164
Reference: 0007700
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Kpb - Blood Grouping Reagent

Anti-Kpb Blood Grouping Reagent

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000785
Basic UDI-DI: 88823401W0103030501C201SQ
Reference: 0007550
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Kpa Blood Grouping Reagent

Anti-Kpa

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000778
Basic UDI-DI: 88823401W0103030501C200SN
Reference: 0007540
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

GammaZyme-B

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000716
Basic UDI-DI: 88823401W0103030307C001TE
Reference: 0007058
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

GammaZyme-F

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000709
Basic UDI-DI: 88823401W0103030307C000TC
Reference: 0007056
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Red Blood Cell (RBC) Storage Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000495
Basic UDI-DI: 88823401W01030399A0000147
Reference: 0005036
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Belgium
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Platelet Wash and Storage Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000488
Basic UDI-DI: 88823401W01030399A0000249
Reference: 0005035
EMDN: W0103010605
EMDN description: PLATELETS
First on market country: Belgium
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

MIA FORA NGS MFlex 6 HLA Typing Kit, 24 test

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 10888234100812
Basic UDI-DI: 88823412W01030403C00000YJ
Reference: SR-800-10535-24
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 21.06.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

MIA FORA NGS MFlex 11 HLA Typing Kit, 96 test

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 10888234100829
Basic UDI-DI: 88823412W01030403C00000YJ
Reference: SR-800-10534-96
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 21.06.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

MIA FORA NGS MFlex 6 HLA Typing Kit, 96 test

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 10888234100843
Basic UDI-DI: 88823412W01030403C00000YJ
Reference: SR-800-10535-96
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 21.06.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

MIA FORA NGS MFlex 11 HT HLA Typing Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 10888234100850
Basic UDI-DI: 88823412W01030403C00000YJ
Reference: SR-800-10534-1152
EMDN: W01030403
EMDN description: HLA ANTIGEN TYPING
First on market country: -
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 21.06.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details