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Atellica CI Dilution Cuvette Segments

IVDR_67_TTN_DUB-C_A_INST_Dilution Cuvette Segment

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414304526
Basic UDI-DI: 0405686901517VL
Reference: 11099501
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA® Chemistry Reagent Probe Wash 3

IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Wash 3

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414210087
Basic UDI-DI: 0405686901582VX
Reference: 10311858
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA® Chemistry Reagent Probe Wash 2

IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Wash 2

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414210070
Basic UDI-DI: 0405686901581VV
Reference: 10311857
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA® Chemistry Reagent Probe Wash 1

IVDR_67_TTN_DUB-C_A_REAG_Reagent Probe Wash 1

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414210056
Basic UDI-DI: 0405686901580VT
Reference: 10311856
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA® Chemistry Cuvette Conditioner

IVDR_67_TTN_DUB-C_A_REAG_Cuvette Conditioner

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414210025
Basic UDI-DI: 0405686901553VQ
Reference: 10311854
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA® Chemistry Cuvette Wash Solution

IVDR_67_TTN_DUB-C_A_REAG_Cuvette Wash Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414210001
Basic UDI-DI: 0405686901554VS
Reference: 10311853
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH 930 Analyzer

IVDR_67_TTN_DUB-C_A_INST_930 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414002163
Basic UDI-DI: 0405686901510V6
Reference: 11067000
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

ALTA Biochemistry Analyzer

ADX-230

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Athenese-Dx Private Limited
Manufacturer SRN: IN-MF-000031022
UDI-DI: G3202301
Basic UDI-DI: ++G320ABA06QL
Reference: ADX-230
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Piccolo Xpress

1100-1001

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

Manufacturer: Abaxis, Inc.
Manufacturer SRN: US-MF-000021651
UDI-DI: EABA11000000EI1
Basic UDI-DI: ++EABA11000000EI5D
Reference: 1100-0000EI
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: ABAXIS Europe GmbH
Last updated: 15.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Piccolo Xpress

1100-1001

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

Manufacturer: Abaxis, Inc.
Manufacturer SRN: US-MF-000021651
UDI-DI: EABA11000000E1
Basic UDI-DI: ++EABA11000000E7F
Reference: 1100-0000E
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: ABAXIS Europe GmbH
Last updated: 15.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Piccolo Xpress

1100-1001R

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

Manufacturer: Abaxis, Inc.
Manufacturer SRN: US-MF-000021651
UDI-DI: +EABA11000000ER1
Basic UDI-DI: ++EABA11000000ER5X
Reference: 1100-0000ER
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: ABAXIS Europe GmbH
Last updated: 15.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE UDR Kit (1-pack)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-PartnumberA097916X
Basic UDI-DI: B-PartnumberA097916X
Reference: A09791
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 15.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

NS BIOTEC Chemistry Analyzer

IVD generalIVDDNo longer on the marketInstrumentProfessional testing

Manufacturer: NS BIOTEC
Manufacturer SRN: EG-MF-000032515
UDI-DI: D-ChemistryAnalyzerHC
Basic UDI-DI: B-ChemistryAnalyzerHC
Reference: SCA 1000/1200
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON UDR Kit (2-pack)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-443729Q7
Basic UDI-DI: B-443729Q7
Reference: 443729
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EZ (SP-4430)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-18306GC
Basic UDI-DI: B-18306GC
Reference: 18306
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EZ (SP-4430)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-18304G8
Basic UDI-DI: B-18304G8
Reference: 18304
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 004 (DB-3910)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105581MS
Basic UDI-DI: B-105581MS
Reference: 105581
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

XL-1000 without ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156145534
Basic UDI-DI: 8592156CCIN0053SL
Reference: INS00010
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: -
Authorised representative: -
Last updated: 08.07.2026 22:49

Manufacturer products View details

XL-640 without ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143202
Basic UDI-DI: 8592156CCIN0052SJ
Reference: INS00008
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: -
Last updated: 08.07.2026 22:49

Manufacturer products View details

XL-200 without ISE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156143851
Basic UDI-DI: 8592156CCIN0051SG
Reference: INS00002
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: -
Authorised representative: -
Last updated: 08.07.2026 22:49

Manufacturer products View details