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652 device results listed.

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Atellica IM DHEAS2 Master Curve Material (DHEAS2 MCM)

IVDR_67_TTN_DUB-C_B_REAG_DHEAS2 MCM

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414632940
Basic UDI-DI: 0405686902312V7
Reference: 11209195
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Neuron-Specific Enolase (NSE)

IVDR_67_TTN_DUB-C_C_REAG_NSE

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414607146
Basic UDI-DI: 0405686902347VS
Reference: 11354592
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 560 Hematology System

IVDR_67_TTN_DUB-C_B_INST_Hematology System

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414601816
Basic UDI-DI: 0405686901597WC
Reference: 11170842
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 560 Control

IVDR_67_TTN_DUB-C_B_REAG_Control

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600840
Basic UDI-DI: 0405686901690W3
Reference: 11170854
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Cyclosporine (CsA)

IVDR_67_TTN_DUB-C_C_CsA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598727
Basic UDI-DI: 0405686901807VY
Reference: 10995548
EMDN: W0102080601
EMDN description: CYCLOSPORINE TOTAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i 3 in 1 TESTpoint CSF Controls

IVDR_67_TTN_DUB-C_B_REAG_CSF Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414472539
Basic UDI-DI: 0405686900782W2
Reference: 10314243
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Anti-CCP IgG Master Curve Material (aCCP MCM)

IVDR_67_TTN_DUB-C_B_REAG_aCCP_MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414245683
Basic UDI-DI: 0405686900756VZ
Reference: 10733000
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Cystatin C_2 Calibrators (CYSC_2 CAL)

IVDR_67_TTN_DUB-C_C_REAG_CYSC_2 CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414238104
Basic UDI-DI: 0405686901846WA
Reference: 11097648
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i TESTpoint Reticulocyte Controls (Low)

IVDR_67_TTN_DUB-C_B_REAG_Reticulocyte Control High

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224428
Basic UDI-DI: 0405686900796WD
Reference: 10312293
EMDN: W0103010506
EMDN description: RETICULOCYTE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i TESTpoint Hematology Controls (High)

IVDR_67_TTN_DUB-C_B_REAG_Control High

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224404
Basic UDI-DI: 0405686900779WD
Reference: 10312291
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i TESTpoint Hematology Controls (Norm)

IVDR_67_TTN_DUB-C_B_REAG_Control Normal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224381
Basic UDI-DI: 0405686900781VY
Reference: 10312289
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i TESTpoint Hematology Controls (Low)

IVDR_67_TTN_DUB-C_B_REAG_Control Low

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224367
Basic UDI-DI: 0405686900780VW
Reference: 10312287
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica SH Additional

IVDR_67_TTN_DUB-C_A_INST_Additional

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414002460
Basic UDI-DI: 0405686902024UX
Reference: 11069004
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

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: 00630414002439
Basic UDI-DI: 0405686902027V5
Reference: 11069001
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Solution Display

IVDR_69_TTN_DUB-C_A_NPT_INST_De-Cent. Urine LumIQ Analyzer

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414633428
Basic UDI-DI: 0405686901935WA
Reference: 1.0
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

DCA® Vantage Analyzer (USA)

IVDR_69_TTN_DUB-C_A_NPT_INST_DCA-ACR

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414551364
Basic UDI-DI: 0405686901932W4
Reference: 10282969
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Plastic Blood Capillaries Multicap-S

IVDR_69_TTN_DUB-C_A_NPT_MultiCaps

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414508276
Basic UDI-DI: 0405686901918WA
Reference: 10313226
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Cytokeratin Fragment 21-1 (CYFRA)

IVDR_67_TTN_DUB-C_C_REAG_CYFRA

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414291345
Basic UDI-DI: 0405686902359VZ
Reference: 11354591
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Display IND, UA, NC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414657219
Basic UDI-DI: 0405686901935WA
Reference: 11702311
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica POC Display IDN/MYS UA NC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414657202
Basic UDI-DI: 0405686901935WA
Reference: 11702310
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details