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879 device results listed.

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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

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414657103
Basic UDI-DI: 0405686901935WA
Reference: 11702306
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

RAPIDPoint® 500 Systems Wash/Waste Cartridge (4)

IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RapidPoint

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414482163
Basic UDI-DI: 0405686901921VX
Reference: 10329097
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 24.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Triglycerides_2 (Trig_2)

IVDR_67_TTN_DUB-C_B_REAG_Atellica CH Trig_2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414610955
Basic UDI-DI: 0405686902138VF
Reference: 11537222
EMDN: W01010231
EMDN description: TRIGLYCERIDES
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

ADVIA 360 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: 00630414601250
Basic UDI-DI: 0405686901597WC
Reference: 11170841
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: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 360 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: 00630414600833
Basic UDI-DI: 0405686901690W3
Reference: 11170853
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
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

ADVIA 360/560 Calibrator

IVDR_67_TTN_DUB-C_B_REAG_Calibrator

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600826
Basic UDI-DI: 0405686901679WF
Reference: 11170852
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
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

Atellica IM C-peptide Calibrator (CpS CAL)

IVDR_67_TTN_DUB-C_B_REAG_C-Peptide Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600420
Basic UDI-DI: 0405686901691W5
Reference: 10995542
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
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

Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL)

IVDR_67_TTN_DUB-C_B_KIT_TSH3-UL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600161
Basic UDI-DI: 0405686901633VP
Reference: 10995703
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
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