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65 device results listed.

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Anti-B Monoclonal

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673700041
Basic UDI-DI: B-08431673700041
Reference: 1700004
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Spain
Authorised representative: -
Last updated: 22.09.2026 10:34

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Anti-A+B Monoclonal

Blood grouping

IVD Annex II List AIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673700065
Basic UDI-DI: B-08431673700065
Reference: 1700006
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Spain
Authorised representative: -
Last updated: 22.09.2026 09:51

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Anti-B Monoclonal

ABO Monoclonal Antibody Reagent

IVD Annex II List AIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Lorne Laboratories Ltd
Manufacturer SRN: GB-MF-000029354
UDI-DI: 05060168050939
Basic UDI-DI: B-05060168050939
Reference: 610010
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 22.09.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-A Monoclonal

ABO Monoclonal Antibody Reagent

IVD Annex II List AIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Lorne Laboratories Ltd
Manufacturer SRN: GB-MF-000029354
UDI-DI: 05060168050854
Basic UDI-DI: B-05060168050854
Reference: 600010
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 22.09.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-A,B Monoclonal

ABO Monoclonal Antibody Reagent

IVD Annex II List AIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Lorne Laboratories Ltd
Manufacturer SRN: GB-MF-000029354
UDI-DI: 05060168051011
Basic UDI-DI: B-05060168051011
Reference: 620010
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 22.09.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

ABO-trol® forte II or Medtrokarte NK4

IVD Annex II List ANot specifiedOn the market

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: 04250861821276
Basic UDI-DI: B-04250861821276
Reference: 01.900-50-2 or NK4
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Germany
Authorised representative: -
Last updated: 06.08.2026 22:51

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ABO-trol® forte plus

IVD Annex II List ANot specifiedOn the market

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: 04250861821283
Basic UDI-DI: B-04250861821283
Reference: 01.901-30-2
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Germany
Authorised representative: -
Last updated: 06.08.2026 22:50

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Medtrokarten NK4

IVD Annex II List ANot specifiedOn the market

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: 04250861815381
Basic UDI-DI: B-04250861815381
Reference: NK4
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 09:35

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Anti-AB monoclonal, IgM clones: ES-15, ES-4

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: 04250861800318
Basic UDI-DI: B-04250861800318
Reference: 01.005-10
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 09:34

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Anti-B monoclonal, IgM clone: LB-2

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: 04250861800219
Basic UDI-DI: B-04250861800219
Reference: 01.003-10
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 09:34

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Anti-A monoclonal, IgM clone: Birma-1

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: 04250861800110
Basic UDI-DI: B-04250861800110
Reference: 01.001-10
EMDN: W0103030102
EMDN description: ABO SERA
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 09:34

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Dolichotest

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620246
Basic UDI-DI: B-05904365620246
Reference: 133
EMDN: W0103030199
EMDN description: ABO TYPING TESTS - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:20

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Standaryzowane Krwinki Wzorcowe do układu ABO

Standardized Red Blood Cells for the ABO group system

IVD Annex II List AIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620079
Basic UDI-DI: B-05904365620079
Reference: 900
EMDN: W0103030101
EMDN description: ABO GROUPING CELLS
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:19

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Standaryzowane Krwinki Wzorcowe typ PBS-VERA do układu ABO

Standardized Red Blood Cells. Set type PBS-VERA for the ABO system definition

IVD Annex II List AIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620062
Basic UDI-DI: B-05904365620062
Reference: 511
EMDN: W0103030101
EMDN description: ABO GROUPING CELLS
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:19

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Konserwowane Krwinki Wzorcowe do układu ABO I

Preserved Standard Red Blood Cells. Set for the ABO system definition I

IVD Annex II List AIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620024
Basic UDI-DI: B-05904365620024
Reference: 576
EMDN: W0103030101
EMDN description: ABO GROUPING CELLS
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:19

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Konserwowane Krwinki Wzorcowe do układu ABO

Preserved Standard Red Blood Cells. Set for the ABO system definition

IVD Annex II List AIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620017
Basic UDI-DI: B-05904365620017
Reference: 508
EMDN: W0103030101
EMDN description: ABO GROUPING CELLS
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:19

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ELDON BAG 2551-V-25

730-07v02

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Eldon Biologicals A/S
Manufacturer SRN: DK-MF-000025470
UDI-DI: 05713494002201
Basic UDI-DI: B-05713494002201
Reference: 730-07
EMDN: W0103030199
EMDN description: ABO TYPING TESTS - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.08.2026 22:55

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ELDONBOX 2551-100

430-01v06

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Eldon Biologicals A/S
Manufacturer SRN: DK-MF-000025470
UDI-DI: 05713494002102
Basic UDI-DI: B-05713494002102
Reference: 430-01
EMDN: W0103030199
EMDN description: ABO TYPING TESTS - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.08.2026 22:54

Manufacturer products View details

ELDON BAG 2551-25

730-05

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Eldon Biologicals A/S
Manufacturer SRN: DK-MF-000025470
UDI-DI: 05713494001945
Basic UDI-DI: B-05713494001945
Reference: 730-05
EMDN: W0103030199
EMDN description: ABO TYPING TESTS - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.08.2026 22:54

Manufacturer products View details

ELDON EMERGENCY PACK 2551-100

630-00v03

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Eldon Biologicals A/S
Manufacturer SRN: DK-MF-000025470
UDI-DI: 05713494001938
Basic UDI-DI: B-05713494001938
Reference: 630-00
EMDN: W0103030199
EMDN description: ABO TYPING TESTS - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 02.08.2026 22:54

Manufacturer products View details