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879 device results listed.

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Atellica CH Calcium (Ca)

IVDR_67_TTN_DUB-C_B_REAG_CA_c

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414654041
Basic UDI-DI: 0405686901672VZ
Reference: 11645759
EMDN: W01010303
EMDN description: CALCIUM
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 High Sensitivity C-Reactive Protein 2 (hCRP2)

IVDR_67_TTN_DUB-C_C_REAG_hCRP2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414611112
Basic UDI-DI: 0405686902330V9
Reference: 11537224
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
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 LDL Cholesterol (LDLC)

IVDR_67_TTN_DUB-C_B_REAG_Atellica CH LDLC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414611037
Basic UDI-DI: 0405686902136VB
Reference: 11537214
EMDN: W01010221
EMDN description: LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
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 HDL Cholesterol (HDLC)

IVDR_67_TTN_DUB-C_B_REAG_Atellica CH HDLC

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414610832
Basic UDI-DI: 0405686902134V7
Reference: 11537213
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
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 Her-2/neu Quality Control (H2n QC)

IVDR_67_TTN_DUB-C_C_REAG_H2n QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599182
Basic UDI-DI: 0405686901854W9
Reference: 10995594
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 IM HER-2/neu Calibrator (H2n CAL)

IVDR_67_TTN_DUB-C_C_REAG_H2n Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599168
Basic UDI-DI: 0405686901853W7
Reference: 10995592
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 IM HER-2/neu (H2n)

IVDR_67_TTN_DUB-C_C_KIT_H2n

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599151
Basic UDI-DI: 0405686901814VV
Reference: 10995591
EMDN: W0102030301
EMDN description: HER-2/NEU
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 Free Triiodothyronine (FT3)

IVDR_67_TTN_DUB-C_B_REAG_FT3

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599090
Basic UDI-DI: 0405686901713VN
Reference: 10995585
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
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 Digoxin (Dig)

IVDR_67_TTN_DUB-C_C_REAG_Digoxin

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598826
Basic UDI-DI: 0405686901848WE
Reference: 10995558
EMDN: W0102080101
EMDN description: DIGOXIN
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 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

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