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02.08.2026 18:51

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27 device results listed.

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ALBAclone® Anti-D blend Monoclonal IgM/IgG

Z041

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 05060242471964
Basic UDI-DI: B-05060242471964
Reference: Z041
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

ALBAclone® Anti-D optimum

Z039

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 05060242471957
Basic UDI-DI: B-05060242471957
Reference: Z039
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

ALBAclone® Anti-D alpha

Z031

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 05060242471933
Basic UDI-DI: B-05060242471933
Reference: Z031
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-D IgG + IgM Monoclonal

Blood grouping

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673700218
Basic UDI-DI: B-08431673700218
Reference: 1700021
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:30

Manufacturer products View details

Anti-D (IgG & IgM) Monoclonal

Monoclonal

IVD Annex II List AIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: D-05060599400358HK
Basic UDI-DI: B-05060599400358HK
Reference: BG-D10
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Poland
Authorised representative: Advena Limited
Last updated: 06.07.2026 08:24

Manufacturer products Authorised representative products Authorised representative actors View details

AIO-RHD FETAL DNA KIT

AIO-RHD FETAL DNA KIT (150)

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GENOTROPY
Manufacturer SRN: FR-MF-000026152
UDI-DI: 03770029504090
Basic UDI-DI: B-03770029504090
Reference: GNPY #010-004
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:34

Manufacturer products View details

AIO-RHD FETAL DNA KIT

AIO-RHD FETAL DNA KIT (300)

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GENOTROPY
Manufacturer SRN: FR-MF-000026152
UDI-DI: 03770029504083
Basic UDI-DI: B-03770029504083
Reference: GNPY #010-005
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:34

Manufacturer products View details

AIO-RHD FETAL DNA KIT

AIO-RHD FETAL DNA KIT (450)

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GENOTROPY
Manufacturer SRN: FR-MF-000026152
UDI-DI: 03770029504076
Basic UDI-DI: B-03770029504076
Reference: GNPY #010-006
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:34

Manufacturer products View details

AIO-RHD FETAL DNA KIT

AIO-RHD FETAL DNA KIT (600)

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GENOTROPY
Manufacturer SRN: FR-MF-000026152
UDI-DI: 03770029504069
Basic UDI-DI: B-03770029504069
Reference: GNPY #010-007
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:34

Manufacturer products View details

AIO-RHD FETAL DNA KIT

AIO-RHD FETAL DNA KIT (750)

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GENOTROPY
Manufacturer SRN: FR-MF-000026152
UDI-DI: 03770029504052
Basic UDI-DI: B-03770029504052
Reference: GNPY #010-008
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:34

Manufacturer products View details

AIO-RHD FETAL DNA KIT

AIO-RHD FETAL DNA KIT (900)

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GENOTROPY
Manufacturer SRN: FR-MF-000026152
UDI-DI: 03770029504045
Basic UDI-DI: B-03770029504045
Reference: GNPY #010-009
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:34

Manufacturer products View details

AIO-RHD FETAL DNA KIT

AIO-RHD FETAL DNA KIT (1200)

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GENOTROPY
Manufacturer SRN: FR-MF-000026152
UDI-DI: 03770029504021
Basic UDI-DI: B-03770029504021
Reference: GNPY #010-011
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:34

Manufacturer products View details

AIO-RHD FETAL DNA KIT

AIO-RHD FETAL DNA KIT (1350)

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GENOTROPY
Manufacturer SRN: FR-MF-000026152
UDI-DI: 03770029504014
Basic UDI-DI: B-03770029504014
Reference: GNPY #010-012
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:34

Manufacturer products View details

AIO-RHD FETAL DNA KIT

AIO-RHD FETAL DNA KIT (1050)

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GENOTROPY
Manufacturer SRN: FR-MF-000026152
UDI-DI: 03770029504038
Basic UDI-DI: B-03770029504038
Reference: GNPY #010-010
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:34

Manufacturer products View details

AIO-RHD FETAL DNA KIT

AIO-RHD FETAL DNA KIT (1500)

IVD Annex II List AIVDDOn the marketKitProfessional testingReagent

Manufacturer: GENOTROPY
Manufacturer SRN: FR-MF-000026152
UDI-DI: 03770029504007
Basic UDI-DI: B-03770029504007
Reference: GNPY #010-013
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:34

Manufacturer products View details

immuClone® Anti-D rapid IgM

immuClone® Anti-D rapid 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: 10888234300243
Basic UDI-DI: 88823405W0103030201D38JK
Reference: 0007117
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Germany
Safety summary (SSCP/SSP): 05.PER.0258 · Rev. 003
Authorised representative: -
Last updated: 03.07.2026 21:09

Manufacturer products Open in EUDAMED View details

immuClone® Anti-D fast IgM

immuClone® Anti-D fast IgM

IVD Class DIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
UDI-DI: 10888234300236
Basic UDI-DI: 88823405W0103030201D37JH
Reference: 0007116
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Germany
Safety summary (SSCP/SSP): 05.PER.0257 · Rev. 003
Authorised representative: -
Last updated: 03.07.2026 21:09

Manufacturer products Open in EUDAMED View details

immuClone Anti-D duo IgM + IgG

immuClone Anti-D duo IgM + IgG

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

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
UDI-DI: 10888234300106
Basic UDI-DI: 88823405W0103030201D36JF
Reference: 0006196
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: Germany
Safety summary (SSCP/SSP): 05.PER.0256 · Rev. 002
Authorised representative: -
Last updated: 03.07.2026 21:09

Manufacturer products Open in EUDAMED View details

immuClone Anti-D duo IgM + IgG

-

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

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
UDI-DI: 10888234300113
Basic UDI-DI: 88823405W0103030201D36JF
Reference: 0006199
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: -
Safety summary (SSCP/SSP): 05.PER.0256 · Rev. 002
Authorised representative: -
Last updated: 21.06.2026 16:13

Manufacturer products Open in EUDAMED View details

immuClone® Anti-D fast IgM

-

IVD Class DIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: IMMUCOR Medizinische Diagnostik GmbH
Manufacturer SRN: DE-MF-000006494
UDI-DI: 10888234300250
Basic UDI-DI: 88823405W0103030201D37JH
Reference: 0007126
EMDN: W0103030201
EMDN description: RHESUS D
First on market country: -
Safety summary (SSCP/SSP): 05.PER.0257 · Rev. 003
Authorised representative: -
Last updated: 21.06.2026 16:13

Manufacturer products Open in EUDAMED View details