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552 device results listed.

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Anti-D monoclonal, human IgM clone: P3x61

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: 04250861800912
Basic UDI-DI: B-04250861800912
Reference: 01.167-10
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 09:34

Manufacturer products View details

Anti-D monoclonal, human IgM clone: RUM-1

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: ANTITOXIN GmbH
Manufacturer SRN: DE-MF-000008156
UDI-DI: 04250861800813
Basic UDI-DI: B-04250861800813
Reference: 01.011-10
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 09:34

Manufacturer products View details

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

Manufacturer products View details

ORTHO™ Sera Reagent Control

6986728 (FD272B)

IVD Annex II List AIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750031566
Basic UDI-DI: B-10758750031566
Reference: 6986728 (FD272B)
EMDN: W0103030499
EMDN description: IMMUNOHAEMATOLOGY CONTROLS - OTHER
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Sera Anti-D (DVI)

6904623 (FD039B)

IVD Annex II List AIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750030170
Basic UDI-DI: B-10758750030170
Reference: 6904623 (FD039B)
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Anti-Leb

6904498 (FD217B)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013241
Basic UDI-DI: B-10758750013241
Reference: 6904498 (FD217B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Anti-Lea

IVD generalNot specifiedOn the market

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013234
Basic UDI-DI: B-10758750013234
Reference: 6904497 (FD212B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Anti-N

6904495 (FD176B)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013227
Basic UDI-DI: B-10758750013227
Reference: 6904495 (FD176B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Sera Anti-M

6904494 (FD171B)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013210
Basic UDI-DI: B-10758750013210
Reference: 6904494 (FD171B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Sera Anti-K

6904492 (FD132B)

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013203
Basic UDI-DI: B-10758750013203
Reference: 6904492 (FD132B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Sera Anti-D (IAT)

6904493 (FD041B)

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013197
Basic UDI-DI: B-10758750013197
Reference: 6904493 (FD041B)
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Anti-s

6904491 (FD186B)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013180
Basic UDI-DI: B-10758750013180
Reference: 6904491 (FD186B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Anti-S

6904490 (FD182B)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013173
Basic UDI-DI: B-10758750013173
Reference: 6904490 (FD182B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Sera Anti-Jkb

6904489 (FD166B)

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013166
Basic UDI-DI: B-10758750013166
Reference: 6904489 (FD166B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Sera Anti-Jka

6904488 (FD162B)

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013159
Basic UDI-DI: B-10758750013159
Reference: 6904488 (FD162B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Sera Anti- Fyb

6904487 (FD153B)

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013142
Basic UDI-DI: B-10758750013142
Reference: 6904487 (FD153B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO™ Sera Anti- Fya

6904486 (FD151B)

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750013135
Basic UDI-DI: B-10758750013135
Reference: 6904486 (FD151B)
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

ORTHO CONFIDENCE™

6842785

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 10758750012862
Basic UDI-DI: B-10758750012862
Reference: 6842785
EMDN: W0103030402
EMDN description: CONTROL KITS (IMMUNOHAEMATOLOGY)
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-human globulin polyspecific

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673700515
Basic UDI-DI: B-08431673700515
Reference: 1700051
EMDN: W0103030304
EMDN description: POLYSPECIFIC ANTIHUMAN SERUM
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

06951045810427

Level 1: 1.2mL×4, Level 2: 1.2mL×4

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045810427
Basic UDI-DI: B-06951045810427
Reference: SDX-57037
EMDN: W0103030499
EMDN description: IMMUNOHAEMATOLOGY CONTROLS - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details