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47 device results listed.

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cobas i601 System Software version 01-05

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336245910
Basic UDI-DI: 761333603524AZ
Reference: 10835290001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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cobas Microbial Inactivation Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336237922
Basic UDI-DI: 761333603542B3
Reference: 10434031001
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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PreciControl HTLV

IVD Class DIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336234464
Basic UDI-DI: 761333603148AT
Reference: 09465014190
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 10:42

Manufacturer products Open in EUDAMED View details

Elecsys DHEA-S II

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336228869
Basic UDI-DI: 761333603391B6
Reference: 09043560214
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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Elecsys DHEA-S II

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336228845
Basic UDI-DI: 761333603390B4
Reference: 09043551214
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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Elecsys Anti-HEV IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336219812
Basic UDI-DI: 761333603453B3
Reference: 09776737190
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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Elecsys EBV IgM

Elecsys Cortisol III

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336219799
Basic UDI-DI: 761333603451AX
Reference: 09776699190
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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Cortisol II

Elecsys Cortisol II

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336218372
Basic UDI-DI: 761333603450AV
Reference: 09755632190
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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Elecsys CA 19-9

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336218341
Basic UDI-DI: 761333603299BH
Reference: 09755608190
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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Elecsys Testosterone II

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336217832
Basic UDI-DI: 761333602858BS
Reference: 09745963190
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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Elecsys Anti-Tg

Elecsys Anti-TG

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336217764
Basic UDI-DI: 761333603328AX
Reference: 09745602190
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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Elecsys T4

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336217719
Basic UDI-DI: 761333603080AJ
Reference: 09744983190
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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Elecsys Tg II

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336217696
Basic UDI-DI: 761333603081AL
Reference: 09744967190
EMDN: W01020408
EMDN description: THYROGLOBULIN
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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Elecsys HTLV-I/II

Elecsys HTLV

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336217108
Basic UDI-DI: 761333603075AR
Reference: 09730826190
EMDN: W0105030702
EMDN description: HTLV MULTIPLE ANTIBODY
First on market country: Germany
Safety summary (SSCP/SSP): 1200000826037 · Rev. 01
Authorised representative: -
Last updated: 13.10.2026 10:42

Manufacturer products Open in EUDAMED View details

AssayTip II

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336179062
Basic UDI-DI: 761333603541AZ
Reference: 08863504001
EMDN: W05039080
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

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CalSet DHEA-S II

Elecsys DHEA-S II

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336172841
Basic UDI-DI: 761333602824B9
Reference: 09043586190
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

Manufacturer products View details

Elecsys DHEA-S II

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336172834
Basic UDI-DI: 761333602823B7
Reference: 09043560190
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

Manufacturer products View details

Elecsys DHEA-S II

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

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336172827
Basic UDI-DI: 761333602822B5
Reference: 09043551190
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Germany
Authorised representative: -
Last updated: 13.10.2026 10:42

Manufacturer products View details

Elecsys HTLV-I/II

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336172070
Basic UDI-DI: 761333602259AW
Reference: 09015272190
EMDN: W0105030702
EMDN description: HTLV MULTIPLE ANTIBODY
First on market country: Germany
Safety summary (SSCP/SSP): 1200000826037 · Rev. 01
Authorised representative: -
Last updated: 13.10.2026 10:42

Manufacturer products Open in EUDAMED View details

Elecsys HTLV-I/II

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336172032
Basic UDI-DI: 761333602257AS
Reference: 09015175190
EMDN: W0105030702
EMDN description: HTLV MULTIPLE ANTIBODY
First on market country: Germany
Safety summary (SSCP/SSP): 1200000826037 · Rev. 01
Authorised representative: -
Last updated: 13.10.2026 10:42

Manufacturer products Open in EUDAMED View details