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47 device results listed.

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PreciControl HTLV-I/II

PreciControl HTLV

IVD Class DIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 04015630940875
Basic UDI-DI: 761333601471AP
Reference: 07108133190
EMDN: W0105080803
EMDN description: RETROVIRUS CONTROLS - INF.IMM.
First on market country: Germany
Safety summary (SSCP/SSP): 1200000826037 · Rev. 01
Authorised representative: -
Last updated: 13.10.2026 09:56

Manufacturer products Open in EUDAMED View details

cobas pro Transport Belt (2 MS)

IVD Class ANot specifiedOn the market

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336245873
Basic UDI-DI: 761333603528B9
Reference: 10604450001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 09.10.2026 08:16

Manufacturer products View details

cobas pro Connection Kit (2 MS)

IVD Class ANot specifiedOn the market

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336245866
Basic UDI-DI: 761333603527B7
Reference: 10604441001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 09.10.2026 08:16

Manufacturer products View details

cobas i601 Language Pack for SW 01-05_EN

IVD Class ANot specifiedOn the market

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336245927
Basic UDI-DI: 761333603525B3
Reference: 10835303001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 09.10.2026 08:16

Manufacturer products View details

Chest Pain Triage algorithm 1.1

IVD Class CNot specifiedOn the market

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336242346
Basic UDI-DI: 761333603460AY
Reference: 09883746001
EMDN: W0201020292
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE
First on market country: Germany
Authorised representative: -
Last updated: 09.10.2026 08:16

Manufacturer products View details

cobas i601 Language Pack for SW 01-05_FR

IVD Class ANot specifiedOn the market

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336245972
Basic UDI-DI: 761333603525B3
Reference: 10835389001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 25.09.2026 22:50

Manufacturer products View details

cobas i601 Language Pack for SW 01-05_JP

IVD Class ANot specifiedOn the market

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336245996
Basic UDI-DI: 761333603525B3
Reference: 10835419001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 25.09.2026 22:50

Manufacturer products View details

cobas i601 Language Pack for SW 01-05_DE

IVD Class ANot specifiedOn the market

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336245965
Basic UDI-DI: 761333603525B3
Reference: 10835362001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 25.09.2026 22:50

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cobas i601 Language Pack for SW 01-05_IT

IVD Class ANot specifiedOn the market

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336245941
Basic UDI-DI: 761333603525B3
Reference: 10835320001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 25.09.2026 22:50

Manufacturer products View details

cobas i601 Language Pack for SW 01-05_PT

IVD Class ANot specifiedOn the market

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336245958
Basic UDI-DI: 761333603525B3
Reference: 10835346001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 25.09.2026 22:50

Manufacturer products View details

cobas i601 Language Pack for SW 01-05_ES

IVD Class ANot specifiedOn the market

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336245934
Basic UDI-DI: 761333603525B3
Reference: 10835311001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: -
Last updated: 25.09.2026 22:50

Manufacturer products View details

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

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336206218
Basic UDI-DI: 761333602383AY
Reference: 09607161001
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 23:09

Manufacturer products View details

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

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336206201
Basic UDI-DI: 761333602382AW
Reference: 09607137001
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 23:09

Manufacturer products View details

VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336206195
Basic UDI-DI: 761333602381AU
Reference: 09606769001
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 23:09

Manufacturer products View details

VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336206171
Basic UDI-DI: 761333602384B2
Reference: 09605584001
EMDN: W01030709
EMDN description: PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 23:09

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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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details