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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Dimension Vista Drugs of Abuse Calibrator

DX_LS_LEGACY_00842768016455

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768016455
Basic UDI-DI: B-00842768016455
Reference: 10445187
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Urinary/Cerebrospinal Fluid Protein Calibrator

DX_LS_LEGACY_00842768016431

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768016431
Basic UDI-DI: B-00842768016431
Reference: 10445178
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Chemistry 4 Calibrator

DX_LS_LEGACY_00842768015816

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768015816
Basic UDI-DI: B-00842768015816
Reference: 10445172
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Drug 1 Calibrator

DX_LS_LEGACY_00842768015762

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768015762
Basic UDI-DI: B-00842768015762
Reference: 10445183
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Urine Benzodiazepines Screen Flex reagent cartridge

DX_LS_LEGACY_00842768015083

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768015083
Basic UDI-DI: B-00842768015083
Reference: 10445118
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:49

Manufacturer products Authorised representative products Authorised representative actors View details

Labstix

IVDR_69_TTN_DUB-C_B_NPT_REAG_MICR_De-Centralized Urin Stat

IVD Class BIVDR 2017/746On the marketMicrobial substancesNear-patient testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414985077
Basic UDI-DI: 0405686901963WF
Reference: 10327901
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry Albumin BCP Reagent

DX_LS_LEGACY_00630414947402

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414947402
Basic UDI-DI: B-00630414947402
Reference: 10711840
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica SH Prime

IVDR_67_TTN_DUB-C_A_INST_Prime

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414660790
Basic UDI-DI: 0405686902027V5
Reference: 11781419
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Clinistix URI-2 Urinary Tract Infection Test Strips

IVDR_69_TTN_DUB-C_C_SELF_REAG_MICR_De-Centralized Urin Stat

IVD Class CIVDR 2017/746On the marketMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414659886
Basic UDI-DI: 0405686901973WJ
Reference: 11834650
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Safety summary (SSCP/SSP): DX026363 · Rev. 1.0
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Atellica IM Enhanced Liver Fibrosis (ELF)

DX LS_LEGACY_00630414618463

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414618463
Basic UDI-DI: B-00630414618463
Reference: 11208118
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Enhanced Liver Fibrosis (ELF)

DX LS_LEGACY_00630414618128

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414618128
Basic UDI-DI: B-00630414618128
Reference: 11207300
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH LDL Cholesterol Calibrator (LDLC CAL)

IVDR_67_TTN_DUB-C_B_REAG_Atellica CH LDLC CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414610870
Basic UDI-DI: 0405686902137VD
Reference: 11537241
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH HDLC Calibrator (HDLC CAL)

IVDR_67_TTN_DUB-C_B_REAG_Atellica CH HDLC CAL

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414610863
Basic UDI-DI: 0405686902135V9
Reference: 11537240
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Systems Active-B12 (AB12) Quality Control

DX_LS_LEGACY_00630414603124

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414603124
Basic UDI-DI: B-00630414603124
Reference: 10995091
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Active-B12 (AB12) assay

DX_LS_LEGACY_00630414603100

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414603100
Basic UDI-DI: B-00630414603100
Reference: 10995088
EMDN: W0102070204
EMDN description: VITAMIN B12
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Tissue Inhibitor of Matrix Metalloproteinase 1 (TIMP‑1)

DX_LS_LEGACY_00630414600086

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600086
Basic UDI-DI: B-00630414600086
Reference: 10995695
EMDN: W0102120105
EMDN description: TISSUE INHIBITOR OF METALLOPROTEINASE 1
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM N‑terminal Propeptide of Type III Procollagen (PIIINP)

DX_LS_LEGACY_00630414599717

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599717
Basic UDI-DI: B-00630414599717
Reference: 10995653
EMDN: W0102120104
EMDN description: PROCOLLAGEN III AMINO TERMINAL PEPTIDE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Total IgE (tIgE)

DX LS_LEGACY_00630414599380

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599380
Basic UDI-DI: B-00630414599380
Reference: 10995615
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Total IgE (tIgE)

DX LS_LEGACY_00630414599373

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599373
Basic UDI-DI: B-00630414599373
Reference: 10995614
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Hyaluronic Acid (HA)

DX_LS_LEGACY_00630414599199

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599199
Basic UDI-DI: B-00630414599199
Reference: 10995595
EMDN: W0102120103
EMDN description: HYALURONIC ACID
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.10.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details