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ITALO M

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: MTD Diagnostics srl
Manufacturer SRN: IT-MF-000053242
UDI-DI: 8053617720016ZF
Basic UDI-DI: B-8053617720016ZF
Reference: CCIM
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 00:58

Manufacturer products View details

VCHEMY S® EVO

EVO-A01

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Chengdu Seamaty Technology Co.,Ltd
Manufacturer SRN: CN-MF-000033937
UDI-DI: 06973947590092
Basic UDI-DI: 6973947590092HC
Reference: EVO-A01
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaner

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: EKF-diagnostic GmbH
Manufacturer SRN: DE-MF-000006416
UDI-DI: 04048534000840
Basic UDI-DI: 4048534AHAAVK
Reference: 3000-6232
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 24.07.2026 22:56

Manufacturer products View details

Cleaner

IVD Class AIVDR 2017/746Not intended for EU marketNear-patient testingProfessional testingSingle use

Manufacturer: EKF-diagnostic GmbH
Manufacturer SRN: DE-MF-000006416
UDI-DI: 14048534002742
Basic UDI-DI: 4048534AHAAVK
Reference: 3000-6233
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:48

Manufacturer products View details

Cleaner

IVD Class AIVDR 2017/746Not intended for EU marketNear-patient testingProfessional testingSingle use

Manufacturer: EKF-diagnostic GmbH
Manufacturer SRN: DE-MF-000006416
UDI-DI: 24048534002749
Basic UDI-DI: 4048534AHAAVK
Reference: 3000-6235
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:48

Manufacturer products View details

05070002421337

Dxcover Control Pack

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Dxcover Limited
Manufacturer SRN: UK-MF-000046906
UDI-DI: 05070002421337
Basic UDI-DI: 50700024213ControlsZB
Reference: DXC-CM-001
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 23.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica HA1C_E High Volume Conversion Kit

IVDR_67_TTN_DUB-C_A_KIT_HA1C_E HIGH VOLUME CONVERSION KIT

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414306179
Basic UDI-DI: 0405686902189VY
Reference: 11470732
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica Lid Keying Feature

IVDR_67_TTN_DUB-C_A_KIT_LID KEYING FEATURE KIT

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414304328
Basic UDI-DI: 0405686902191VK
Reference: 11597266
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica HA1C_E High Volume Labels (50)

IVDR_67_TTN_DUB-C_A_KIT_HIGH VOLUME LABEL KIT

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414304311
Basic UDI-DI: 0405686902192VM
Reference: 11597090
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica HA1C_E High Volume Bottles (5)

IVDR_67_TTN_DUB-C_A_KIT_HIGH VOLUME BOTTLE KIT

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414304304
Basic UDI-DI: 0405686902190VH
Reference: 11597087
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension CHK Flex reagent cartridge

IVDR_67_GLA_DUB-C_A_REAG_CHK

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768033124
Basic UDI-DI: 0405686901028UY
Reference: 10481507
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Sample Probe Cleaner

IVDR_67_GLA_DUB-C_A_REAG_Small Probe Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016356
Basic UDI-DI: 0405686901042US
Reference: 10445209
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Cuvette Wash Solution

IVDR_67_GLA_DUB-C_A_REAG_Cuvette Wash Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016332
Basic UDI-DI: 0405686901030UK
Reference: 10445207
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

MC-200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600336
Basic UDI-DI: 695441762203C1Z8
Reference: NA
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 22.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600343
Basic UDI-DI: 695441762203C1Z8
Reference: NA
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 22.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry XPT Cuvette Detergent

IVDR_67_TTN_DUB-C_A_REAG_XPT Cuvette Detergent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595474
Basic UDI-DI: 0405686901591VY
Reference: 10718753
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CI Reaction Cuvette Segments

IVDR_67_TTN_DUB-C_A_INST_Reaction Cuvette Segment

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414304519
Basic UDI-DI: 0405686901524VH
Reference: 11099500
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Cuvette Clean

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145179382
Basic UDI-DI: 04033145CC18973FG
Reference: 18973
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 18.07.2026 09:26

Manufacturer products View details

Dimension Vista Reagent Probe Cleaner

IVDR_67_GLA_DUB-C_A_REAG_Reagent Probe Cleaner

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016349
Basic UDI-DI: 0405686901039V5
Reference: 10445208
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur XPT Immunoassay System

IVDR_67_TTN_DUB-C_A_INST_ADVIA Centaur XPT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596914
Basic UDI-DI: 0405686902025UZ
Reference: 10711433
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details