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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

URA - CLINICAL CHEMISTRY ANALYZER

UR-A

IVD generalIVDDNo longer on the marketInstrument

Manufacturer: Medsource Ozone Biomedicals Private Limited
Manufacturer SRN: IN-MF-000042128
UDI-DI: D-MOBPLUR-AVJ
Basic UDI-DI: B-MOBPLUR-AVJ
Reference: UR-A
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 05:08

Manufacturer products Authorised representative products Authorised representative actors View details

URA PREMIO - CLINICAL CHEMISTRY ANALYZER

EC9005

IVD generalIVDDNo longer on the marketInstrument

Manufacturer: Medsource Ozone Biomedicals Private Limited
Manufacturer SRN: IN-MF-000042128
UDI-DI: D-MOBPLEC9005PD
Basic UDI-DI: B-MOBPLEC9005PD
Reference: EC9005
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 05:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-HYDRA09PLUSTD

Hydra 09 Plus

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-HYDRA09PLUSTD
Basic UDI-DI: B-HYDRA09PLUSTD
Reference: NHY09
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 00:59

Manufacturer products 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

UF-5000

Fully Automated Urine Particle Analyzer UF-5000

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BN344411X6
Basic UDI-DI: B-BN344411X6
Reference: BN344411
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:28

Manufacturer products Authorised representative products Authorised representative actors View details

UC-3500

Fully Automated Urine Particle Analyzer UC-3500

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BH756473X3
Basic UDI-DI: B-BH756473X3
Reference: BH756473
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:24

Manufacturer products Authorised representative products Authorised representative actors View details

UF-4000

Fully Automated Urine Particle Analyzer UF-4000

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: D-BA212287P4
Basic UDI-DI: B-BA212287P4
Reference: BA212287
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 13.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

Concentrated Washing Solution 3

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-79053JF
Basic UDI-DI: B-79053JF
Reference: 79053
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:27

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

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20707FM
Basic UDI-DI: B-20707FM
Reference: 20707
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20705FH
Basic UDI-DI: B-20705FH
Reference: 20705
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20704FF
Basic UDI-DI: B-20704FF
Reference: 20704
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem BA (PA-4140)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20504F5
Basic UDI-DI: B-20504F5
Reference: 20504
EMDN: W0201010203
EMDN description: BLOOD-AMMONIA CHECKERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details