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Atellica IM Complexed Prostate-Specific Antigen (cPSA)

IVDR_67_TTN_DUB-C_C_KIT_cPSA

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598680
Basic UDI-DI: 0405686901806VW
Reference: 10995544
EMDN: W0102030115
EMDN description: COMPLEXED PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM BR 27.29 Pretreatment Reagent (BR PRE)

IVDR_67_TTN_DUB-C_C_REAG_BR Pretreatment

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598079
Basic UDI-DI: 0405686901827W6
Reference: 10995480
EMDN: W0102030110
EMDN description: CANCER ANTIGEN 27.29
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur XPT Immunoassay System

IVDR_67_TTN_DUB-C_A_INST_ADVIA Centaur XPT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596914
Basic UDI-DI: 0405686902025UZ
Reference: 10711433
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Carcinoembryonic Antigen (CEA)

IVDR_67_TTN_DUB-C_C_KIT_CEA

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598505
Basic UDI-DI: 0405686901803VQ
Reference: 10995523
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM BR 27.29 Calibrator (BR CAL)

IVDR_67_TTN_DUB-C_C_REAG_BR CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598420
Basic UDI-DI: 0405686901826W4
Reference: 10995515
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Cholesterol_2 (Chol_2)

IVDR_67_TTN_DUB-C_B_REAG_CHOL_c

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596327
Basic UDI-DI: 0405686901683W6
Reference: 11097609
EMDN: W01010205
EMDN description: CHOLESTEROL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Gentamicin (Gent)

IVDR_67_TTN_DUB-C_C_REAG_Gentamicin

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595979
Basic UDI-DI: 0405686901715VS
Reference: 11097516
EMDN: W0102080207
EMDN description: PHENOBARBITAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Acetaminophen (Acet)

IVDR_67_TTN_DUB-C_C_REAG_ACET

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595894
Basic UDI-DI: 0405686900811VG
Reference: 11097522
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry XPT Probe Wash 0

IVDR_67_TTN_DUB-C_A_REAG_XPT Probe Wash 0

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595504
Basic UDI-DI: 0405686901592W2
Reference: 10718756
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Creatinine Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_CREA2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414595009
Basic UDI-DI: 0405686902016UY
Reference: 10872079
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur HAV Total (aHAVT) Quality Control

IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414481883
Basic UDI-DI: 0405686900759W7
Reference: 10322682
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur aHAVT assay

IVDR_67_TTN_DUB-C_B_KIT_aHAVT

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414481876
Basic UDI-DI: 0405686900748W2
Reference: 10322676
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur CA 125II

IVDR_67_TTN_DUB-C_C_KIT_CA 125II

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414461304
Basic UDI-DI: 0405686901800VJ
Reference: 10315696
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur cPSA 1,2,3 Quality Control Material

IVDR_67_TTN_DUB-C_C_REAG_cPSA QC

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414451732
Basic UDI-DI: 0405686901840VW
Reference: 10310387
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur cPSA Pretreatment Reagent

IVDR_67_TTN_DUB-C_C_REAG_cPSA Pretreatment

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414451558
Basic UDI-DI: 0405686901839WD
Reference: 10310384
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator Y (CAL Y)

IVDR_67_TTN_DUB-C_C_REAG_CAL Y

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414451114
Basic UDI-DI: 0405686901833VZ
Reference: 10310383
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI BRAHMS Procalcitonin Calibrator (PCT CAL)

IVDR_67_GLA_DUB-C_C_REAG_LOCI PCT CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414238708
Basic UDI-DI: 0405686902023UV
Reference: 11354448
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

IVDR_67_GLA_DUB-C_C_REAG_LOCI PCT

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414238692
Basic UDI-DI: 0405686902022UT
Reference: 11354447
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

IVDR_67_TTN_DUB-C_C_KIT_A1c_E

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414220505
Basic UDI-DI: 0405686900745VU
Reference: 11097536
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Chemistry ISE Buffer

IVDR_67_TTN_DUB-C_A_REAG_ISE Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414209968
Basic UDI-DI: 0405686900741VL
Reference: 10311849
EMDN: W0101070302
EMDN description: ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details