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879 device results listed.

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

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600178
Basic UDI-DI: 0405686901633VP
Reference: 10995704
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

DCA Vantage Analyzer (Professional Use)

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: 00630414551371
Basic UDI-DI: 0405686901932W4
Reference: 10282970
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Aspartate Aminotransferase (AST)

IVDR_67_TTN_DUB-C_B_REAG_AST_c

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596341
Basic UDI-DI: 0405686901662VW
Reference: 11097607
EMDN: W01010110
EMDN description: ASPARTATE AMINO-TRANSFERASE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:11

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Acid/Base

IVDR_67_TTN_DUB-C_A_REAG_Acid/Base

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595542
Basic UDI-DI: 0405686901541VH
Reference: 11098500
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:11

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry XPT ISE Baseline Solution

IVDR_67_TTN_DUB-C_A_REAG_ISE Baseline Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595498
Basic UDI-DI: 0405686900740VJ
Reference: 10718755
EMDN: W0101070302
EMDN description: ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:11

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry XPT ISE Buffer 2

IVDR_67_TTN_DUB-C_A_REAG_ISE Buffer 2

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595481
Basic UDI-DI: 0405686900742VN
Reference: 10718754
EMDN: W0101070302
EMDN description: ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:11

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

IMMULITE Ascorbic Acid

IVDR_67_TTN_DUB-C_B_REAG_Ascorbic Acid

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414570587
Basic UDI-DI: 0405686901659W9
Reference: 10485435
EMDN: W0102010114
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)
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

ADVIA Centaur Acid/Base Reagents

IVDR_67_TTN_DUB-C_A_REAG_Acid / Base Reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414503875
Basic UDI-DI: 0405686901540VF
Reference: 10313526
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
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

ADVIA Centaur Insulin Diluent

IVDR_67_TTN_DUB-C_A_REAG_IRI_Dil

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414466187
Basic UDI-DI: 0405686900739VZ
Reference: 10310462
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
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 IM Androstenedione (ANDRO)

IVDR_67_TTN_DUB-C_B_KIT_ANDRO

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414285566
Basic UDI-DI: 0405686901601VA
Reference: 11200558
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
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

ADVIA Centaur Acid/Base Reagents

IVDR_67_TTN_DUB-C_A_REAG_Acid / Base

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414190860
Basic UDI-DI: 0405686901539VW
Reference: 10310026
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
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 IM Cytokeratin Fragment Calibrator 21-1 (CYFRA CAL)

IVDR_67_TTN_DUB-C_C_REAG_CYFRA CAL

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414622804
Basic UDI-DI: 0405686902360VJ
Reference: 11553957
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur aTPOII Master Curve Material (aTPOII MCM)

IVDR_67_TTN_DUB-C_B_REAG_aTPOII MCM

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414608822
Basic UDI-DI: 0405686902271VJ
Reference: 11203693
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Androstenedione Master Curve Material (ANDRO MCM)

IVDR_67_TTN_DUB-C_B_REAG_ANDRO MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414603438
Basic UDI-DI: 0405686901654VX
Reference: 10997268
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM C-peptide (CpS)

IVDR_67_TTN_DUB-C_B_KIT_C-Peptide

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600413
Basic UDI-DI: 0405686901607VN
Reference: 10995541
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 2120 and ADVIA 2120i RBC Flow Cell Wash

IVDR_67_TTN_DUB-C_A_REAG_RBC Flow Cell Wash Kit

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768027369
Basic UDI-DI: 0405686900795WB
Reference: 10734561
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 2120 and ADVIA 2120i Perox Flow Cell Wash

IVDR_67_TTN_DUB-C_A_REAG_Perox Flow Cell Wash Kit

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768027345
Basic UDI-DI: 0405686900792W5
Reference: 11306489
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 2120 and ADVIA 2120i Aspiration Pathway Wash

IVDR_67_TTN_DUB-C_A_KIT_Aspiration Pathway Wash Kit

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768027338
Basic UDI-DI: 0405686900749W4
Reference: 11306490
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 2120 and ADVIA 2120i Vent Line Wash

IVDR_67_TTN_DUB-C_A_INST_Vent Line Wash Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768027307
Basic UDI-DI: 0405686900842VT
Reference: 11306492
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details