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652 device results listed.

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Atellica CH Anti-Streptolysin-O_3 (ASO_3)

IVDR_67_TTN_DUB-C_B_REAG_ASO_3

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414610856
Basic UDI-DI: 0405686902306VC
Reference: 11537212
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Iron3 (Iron3)

IVDR_67_TTN_DUB-C_B_REAG_Iron3

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414610849
Basic UDI-DI: 0405686902345VN
Reference: 11537211
EMDN: W0102070106
EMDN description: IRON (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Tumor Marker Quality Control (TM QC)

IVDR_67_TTN_DUB-C_C_REAG_TM QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414608273
Basic UDI-DI: 0405686902362VN
Reference: 11538186
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur NT-proBNP (PBNP) Master Curve Material (MCM)

IVDR_67_TTN_DUB-C_C_REAG_PBNP MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414602899
Basic UDI-DI: 0405686901861W6
Reference: 10994359
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA® 560 Lyse

IVDR_67_TTN_DUB-C_A_REAG_Lyse

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414601878
Basic UDI-DI: 0405686901744VZ
Reference: 11170846
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: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA® 360 Lyse 3P Diff

IVDR_67_TTN_DUB-C_A_REAG_Lyse 3P Diff

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414601281
Basic UDI-DI: 0405686901745W3
Reference: 11170848
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: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Sex Hormone Binding Globulin Calibrator (SHBG CAL)

IVDR_67_TTN_DUB-C_B_REAG_SHBG Calibrator

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599861
Basic UDI-DI: 0405686901770W2
Reference: 10995673
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Rubella IgM Quality Control (Rub M QC)

IVDR_67_TTN_DUB-C_C_REAG_Rubella M Quality Control Material

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599847
Basic UDI-DI: 0405686901867WJ
Reference: 10995669
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Creatine Kinase MB Calibrator (CKMB CAL)

IVDR_67_TTN_DUB-C_C_REAG_CKMB Calibrator

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598598
Basic UDI-DI: 0405686901905VZ
Reference: 10995532
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Calibrator D (CAL D)

IVDR_67_TTN_DUB-C_C_REAG_CAL D

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598376
Basic UDI-DI: 0405686901831VV
Reference: 10995510
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM CA 15-3 Calibrator (CA15-3 CAL)

IVDR_67_TTN_DUB-C_C_REAG_CA 15-3 Calibrator

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598147
Basic UDI-DI: 0405686901829WA
Reference: 10995487
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM CA 125II Calibrator (CA 125II CAL)

IVDR_67_TTN_DUB-C_C_REAG_CA 125II Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598109
Basic UDI-DI: 0405686901828W8
Reference: 10995483
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Toxicology Calibrator (TOX CAL)

IVDR_67_TTN_DUB-C_B_REAG_TOX CAL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597614
Basic UDI-DI: 0405686901780W5
Reference: 11099440
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Chemistry Calibrator (CHEM CAL)

IVDR_67_TTN_DUB-C_C_REAG_Chemistry Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597492
Basic UDI-DI: 0405686901837W9
Reference: 11099411
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH DRUG CAL (DRUG CAL)

IVDR_67_TTN_DUB-C_B_REAG_DRUG CAL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597386
Basic UDI-DI: 0405686901697WH
Reference: 11099336
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH ENZ 1 Calibrator (ENZ 1 CAL)

IVDR_67_TTN_DUB-C_B_REAG_ENZ 1 CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597225
Basic UDI-DI: 0405686901704VM
Reference: 11099317
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Albumin (Alb)

IVDR_67_TTN_DUB-C_B_REAG_ALB_c

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596501
Basic UDI-DI: 0405686901648W4
Reference: 11097590
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH ENZ 3 Calibrator (ENZ 3 CAL)

IVDR_67_TTN_DUB-C_C_REAG_ENZ 3 CAL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597249
Basic UDI-DI: 0405686901706VR
Reference: 11099319
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Alanine Aminotransferase (ALT)

IVDR_67_TTN_DUB-C_B_REAG_ALT_c

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596365
Basic UDI-DI: 0405686901650VP
Reference: 11097605
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Uric Acid (UA)

IVDR_67_TTN_DUB-C_B_REAG_UA_c

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596334
Basic UDI-DI: 0405686901791WA
Reference: 11097608
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details