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01.08.2026 01:12

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566 device results listed.

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Dimension Enzyme Verifier

IVDR_67_GLA_DUB-C_B_REAG_Enzyme Verifier

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768004988
Basic UDI-DI: 0405686901104UP
Reference: 10445016
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH CO2 Calibrator/Diluent (CO2 CAL)

IVDR_67_TTN_DUB-C_B_REAG_CO2 Calibrator/Diluent

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597447
Basic UDI-DI: 0405686901685WA
Reference: 11099401
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem ApoA1/B Calibrator

AutoChem B801

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253012550
Basic UDI-DI: B-06942253012550
Reference: 360103AA10S11
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem HDL/LDL-CHO Calibrator

AutoChem B801

IVD generalIVDDNo longer on the marketKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253012482
Basic UDI-DI: B-06942253012482
Reference: 360103HDL0S11
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem IMM Calibrator

AutoChem B801

IVD generalIVDDNo longer on the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253012093
Basic UDI-DI: B-06942253012093
Reference: 360113MMS9S12
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem IMM Calibrator

AutoChem B801

IVD generalIVDDNo longer on the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253012086
Basic UDI-DI: B-06942253012086
Reference: 360113MMS9S11
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Enzyme II Calibrator

IVDR_67_GLA_DUB-C_B_REAG_Enzyme II Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768034329
Basic UDI-DI: 0405686901103UM
Reference: 10476170
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
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 AHDL Calibrator

IVDR_67_GLA_DUB-C_B_REAG_AHDL CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022012
Basic UDI-DI: 0405686901055V3
Reference: 10464328
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
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 Bilirubin Calibrator

IVDR_67_GLA_DUB-C_B_REAG_DBI CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016813
Basic UDI-DI: 0405686901094VD
Reference: 10445013
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
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 Total Protein/Albumin Calibrator

IVDR_67_GLA_DUB-C_B_REAG_TP/AB CAL

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005091
Basic UDI-DI: 0405686901206UY
Reference: 10444993
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
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

04260674450495

KC-Cal TE

IVD generalIVDDOn the marketProfessional testing

Manufacturer: invicon diagnostic concepts GmbH
Manufacturer SRN: DE-MF-000031071
UDI-DI: 04260674450495
Basic UDI-DI: B-04260674450495
Reference: 150310
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 23.07.2026 02:12

Manufacturer products View details

Cromatest

Albumin Standard

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873001151
Basic UDI-DI: B-84352873001151
Reference: 1901005
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Spain
Authorised representative: -
Last updated: 23.07.2026 00:49

Manufacturer products View details

Dimension Chemistry III Calibrator

IVDR_67_GLA_DUB-C_B_REAG_Chemistry III Calibrator

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414948034
Basic UDI-DI: 0405686901081V4
Reference: 10711580
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem Multi Calibrator

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253012239
Basic UDI-DI: B-06942253012239
Reference: 360113MCS9S12
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem Multi Calibrator

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253012222
Basic UDI-DI: B-06942253012222
Reference: 360113MCS9S11
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Alkaline Phosphatase calibrator

IVDR_67_GLA_DUB-C_B_REAG_ALPI_Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768039027
Basic UDI-DI: 0405686900199VM
Reference: 10714028
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Multical

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182722814
Basic UDI-DI: B-62230182722814
Reference: D-751 001
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 20.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension CKI/MBI Calibrator

IVDR_67_GLA_DUB-C_B_REAG_CKI/MBI CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768025549
Basic UDI-DI: 0405686901085VC
Reference: 10464508
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
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

Dimension Total/Free Prostate Specific Antigen Calibrator

IVDR_67_GLA_DUB-C_C_REAG_Total/Free PSA Cal

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013751
Basic UDI-DI: 0405686901313V2
Reference: 10445031
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
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

Dimension Chemistry I Calibrator

IVDR_67_GLA_DUB-C_C_REAG_Chemistry I Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414948492
Basic UDI-DI: 0405686901241V2
Reference: 10716280
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details