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12 device results listed.

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CoaguChek XS System

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingSelf testing

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 04015630945719
Basic UDI-DI: B-04015630945719
Reference: 04625412170
EMDN: W02020602
EMDN description: RAPID TEST HEMOSTASIS INSTRUMENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 22:42

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CoaguChek INRange

IVD self-testing devicesIVDDOn the marketInstrumentSelf testing

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 04015630942251
Basic UDI-DI: B-04015630942251
Reference: 07404379170
EMDN: W02020602
EMDN description: RAPID TEST HEMOSTASIS INSTRUMENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 22:42

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Elecsys PTH

PTH Elecsys E2G 300 V2

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336199756
Basic UDI-DI: 761333603169B3
Reference: 08928428214
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 06:00

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VENTANA PD-L1 (SP263) Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 04015630976478
Basic UDI-DI: 7613336020019M
Reference: 07419821001
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Safety summary (SSCP/SSP): SSP-0505 · Rev. 3
Authorised representative: -
Last updated: 03.07.2026 05:57

Manufacturer products Open in EUDAMED View details

Elecsys IGRA TB

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336228609
Basic UDI-DI: 761333602954BP
Reference: 09989951190
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Germany
Authorised representative: -
Last updated: 30.06.2026 12:50

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IGRA TB CS Elecsys

CalSet IGRA TB

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336224908
Basic UDI-DI: 761333602953BM
Reference: 09989960190
EMDN: W0105080901
EMDN description: BACTERIOLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 30.06.2026 12:50

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VENTANA anti-PMS2 (SP487) Mouse Monoclonal Primary Antibody

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336220030
Basic UDI-DI: 761333603531AW
Reference: 09785370001
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 30.06.2026 12:50

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Elecsys CK-MB

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336219737
Basic UDI-DI: 761333603115AC
Reference: 07027087214
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: -
Last updated: 30.06.2026 12:50

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VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336119389
Basic UDI-DI: 7613336012019Q
Reference: 08033692001
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 30.06.2026 12:50

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VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336119372
Basic UDI-DI: 761333601199AW
Reference: 08033684001
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 30.06.2026 12:50

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VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336119365
Basic UDI-DI: 7613336012009N
Reference: 08033676001
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 30.06.2026 12:50

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VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336119358
Basic UDI-DI: 761333601197AS
Reference: 08033668001
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 30.06.2026 12:50

Manufacturer products View details