- Manufacturer
- Roche Diagnostics GmbH
- Manufacturer SRN
- DE-MF-000006260
- UDI-DI
- 04015630940875
- Basic UDI-DI
- 761333601471AP
- Reference
- 07108133190
- EMDN
- -
- EMDN description
- -
- First on market country
- -
- Authorised representative
- -
- Last updated
- 22.09.2026 03:11
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
22.09.2026 08:45
Sync status
Successful
Device
3535191
Actor
47706
Certificate
3367
IVD Class DNot specifiedOn the market
IVD Class DNot specifiedOn the market
- Manufacturer
- Roche Diagnostics GmbH
- Manufacturer SRN
- DE-MF-000006260
- UDI-DI
- 07613336172032
- Basic UDI-DI
- 761333602257AS
- Reference
- 09015175190
- EMDN
- -
- EMDN description
- -
- First on market country
- -
- Authorised representative
- -
- Last updated
- 22.09.2026 03:11
IVD Class DNot specifiedOn the market
- Manufacturer
- Roche Diagnostics GmbH
- Manufacturer SRN
- DE-MF-000006260
- UDI-DI
- 07613336234464
- Basic UDI-DI
- 761333603148AT
- Reference
- 09465014190
- EMDN
- -
- EMDN description
- -
- First on market country
- -
- Authorised representative
- -
- Last updated
- 22.09.2026 03:11
IVD Class DNot specifiedOn the market
- Manufacturer
- Roche Diagnostics GmbH
- Manufacturer SRN
- DE-MF-000006260
- UDI-DI
- 07613336217108
- Basic UDI-DI
- 761333603075AR
- Reference
- 09730826190
- EMDN
- -
- EMDN description
- -
- First on market country
- -
- Authorised representative
- -
- Last updated
- 22.09.2026 03:00
IVD Class DNot specifiedOn the market
- Manufacturer
- Roche Diagnostics GmbH
- Manufacturer SRN
- DE-MF-000006260
- UDI-DI
- 07613336172070
- Basic UDI-DI
- 761333602259AW
- Reference
- 09015272190
- EMDN
- -
- EMDN description
- -
- First on market country
- -
- Authorised representative
- -
- Last updated
- 22.09.2026 01:53
IVD Class ANot specifiedOn the market
- Manufacturer
- Roche Diagnostics GmbH
- Manufacturer SRN
- DE-MF-000006260
- UDI-DI
- 07613336237922
- Basic UDI-DI
- 761333603542B3
- Reference
- 10434031001
- EMDN
- -
- EMDN description
- -
- First on market country
- -
- Authorised representative
- -
- Last updated
- 21.09.2026 22:25
VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody
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
VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody
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
VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody
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
VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody
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
CoaguChek XS System
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
CoaguChek INRange
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
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
VENTANA PD-L1 (SP263) Assay
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
Elecsys IGRA TB
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
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
VENTANA anti-PMS2 (SP487) Mouse Monoclonal Primary Antibody
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
Elecsys CK-MB
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
VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody
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
VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody
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