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652 device results listed.

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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

Atellica POC Display IDN/MYS, UA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414657028
Basic UDI-DI: 0405686901935WA
Reference: 11702305
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

Atellica LumIQ Module OUS3

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414656427
Basic UDI-DI: 0405686901935WA
Reference: 11702304
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

Atellica IM Total Triiodothyronine Diluent (T3 DIL)

IVDR_67_TTN_DUB-C_A_REAG_T3 Diluent

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599939
Basic UDI-DI: 0405686901583VZ
Reference: 10995680
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
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 Cyclosporine Calibrator (CsA CAL)

IVDR_67_TTN_DUB-C_C_REAG_CsA Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598734
Basic UDI-DI: 0405686901841VY
Reference: 10995549
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND 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 CH Lipoprotein(a) Calibrator (Lp(a) CAL)

IVDR_67_TTN_DUB-C_B_REAG_LPA CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597546
Basic UDI-DI: 0405686901742VV
Reference: 11099433
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND 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 CH DRUG CAL II (DRUG CAL II)

IVDR_67_TTN_DUB-C_C_REAG_DRUG CAL II

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597485
Basic UDI-DI: 0405686901850VZ
Reference: 11099405
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND 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 CH CO2 Calibrator/Diluent (CO2 CAL)

IVDR_67_TTN_DUB-C_B_REAG_CO2 Calibrator/Diluent

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597447
Basic UDI-DI: 0405686901685WA
Reference: 11099401
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
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 CH Creatinine_2 (Crea_2)

IVDR_67_TTN_DUB-C_C_REAG_CRE_2c

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596457
Basic UDI-DI: 0405686900816VS
Reference: 11097596
EMDN: W01010207
EMDN description: CREATININE
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 CH Iron_2 (Iron_2)

IVDR_67_TTN_DUB-C_B_REAG_IRON_2

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596402
Basic UDI-DI: 0405686901734VW
Reference: 11097601
EMDN: W01010216
EMDN description: IRON (CC)
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 CH Lipase (Lip)

IVDR_67_TTN_DUB-C_B_REAG_LIP

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596358
Basic UDI-DI: 0405686901738W6
Reference: 11097606
EMDN: W01010123
EMDN description: LIPASE
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 CH Transferrin (Trf)

IVDR_67_TTN_DUB-C_B_REAG_Transferrin

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596297
Basic UDI-DI: 0405686901786WH
Reference: 11097613
EMDN: W0102010307
EMDN description: TRANSFERRIN
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 CH Immunoglobulin G_2 (IgG_2)

IVDR_67_TTN_DUB-C_B_REAG_IGG_2

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596266
Basic UDI-DI: 0405686901728W3
Reference: 11097616
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
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