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TU100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763921
Basic UDI-DI: 5065023763TU10001ZG
Reference: TU10001
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 21:40

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDiver Instrument 2

INSTRUMENT II

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023685044
Basic UDI-DI: 5425023685044W7
Reference: BLUEDIVER2
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: -
Last updated: 04.08.2026 21:39

Manufacturer products View details

05070002421344

Dxcover Control Pack

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

Manufacturer: Dxcover Limited
Manufacturer SRN: UK-MF-000046906
UDI-DI: 05070002421344
Basic UDI-DI: 50700024213ControlsZB
Reference: DXC-CS-001
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 04.08.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

SA-53 Sampler Unit

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562515837
Basic UDI-DI: 4987562SA-532E
Reference: CS453361
EMDN: W020101020180
EMDN description: AUTOMATED URINE ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 04.08.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

HM-JACK Sample Cup

HM-JACKarcⅡ

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295531517
Basic UDI-DI: 4987295BU002ZT
Reference: 53151
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 21:33

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: 00630414651637
Basic UDI-DI: 0405686901510V6
Reference: 11768553
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: 04.08.2026 20:55

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Atellica IM 1600 Analyzer

IVDR_67_TTN_DUB-C_A_INST_1600 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414650623
Basic UDI-DI: 0405686901509VM
Reference: 11764888
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

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Atellica IM 1300 Analyzer

IVDR_67_TTN_DUB-C_A_INST_1300 Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414650579
Basic UDI-DI: 0405686901508VK
Reference: 11764765
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica SH Additional

IVDR_67_TTN_DUB-C_A_INST_Additional

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414002460
Basic UDI-DI: 0405686902024UX
Reference: 11069004
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica SH Prime

IVDR_67_TTN_DUB-C_A_INST_Prime

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414002439
Basic UDI-DI: 0405686902027V5
Reference: 11069001
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

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Avoximeter

AVOX1000E-INT

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Accriva Diagnostics, Inc.
Manufacturer SRN: US-MF-000009902
UDI-DI: 10711234530016
Basic UDI-DI: B-10711234530016
Reference: AVOX1000E-INT
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 04.08.2026 17:48

Manufacturer products Authorised representative products Authorised representative actors View details

Avoximeter

C100B

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: Accriva Diagnostics, Inc.
Manufacturer SRN: US-MF-000009902
UDI-DI: 10711234160022
Basic UDI-DI: B-10711234160022
Reference: C100B
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 04.08.2026 17:48

Manufacturer products Authorised representative products Authorised representative actors View details

Avoximeter

E-QCYO

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: Accriva Diagnostics, Inc.
Manufacturer SRN: US-MF-000009902
UDI-DI: 10711234160015
Basic UDI-DI: B-10711234160015
Reference: E-QCYO
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 04.08.2026 17:48

Manufacturer products Authorised representative products Authorised representative actors View details

Gmate® Origin

PG-310

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: GB Lifecare Co., Ltd.
Manufacturer SRN: KR-MF-000039508
UDI-DI: 08809301167793
Basic UDI-DI: B-08809301167793
Reference: PG301-INT
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

FIAPro™ Multi-Channel Immunoflourescence Analyzer

VMFIA1002

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentNear-patient testingProfessional testing

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548252616
Basic UDI-DI: B-08683548252616
Reference: VMFIA1002
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 09:30

Manufacturer products View details

FIAPro™ Immunofluorescence Analyzer

VMFIA1001

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548252289
Basic UDI-DI: B-08683548252289
Reference: VMFIA1001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:30

Manufacturer products View details

06935740753630

IVD Class ANot specifiedOn the marketDirect markingInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740753630
Basic UDI-DI: 69357407IUC000002WV
Reference: UYUC00000203
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO H Link Blood Glucose/Blood β-Ketone Test Meter (Meter Only)

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

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323059486
Basic UDI-DI: 880911590OGPH05HLMG9
Reference: OG-PH05-HLM
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Cradle

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

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323059462
Basic UDI-DI: 880911590OGPH05HLMG9
Reference: OG-PH05-HLR
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Auto-Chemistry Analyzer

CS-1600

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202258664
Basic UDI-DI: B-06942202258664
Reference: CS-1600
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:18

Manufacturer products Authorised representative products Authorised representative actors View details