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216 device results listed.

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HumaLyte Plus 5

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Human Gesellschaft für Biochemica und Diagnostica mbH
Manufacturer SRN: DE-MF-000025590
UDI-DI: 04033145198512
Basic UDI-DI: 04033145CC17470/20EH
Reference: 17470/20
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Romania
Authorised representative: -
Last updated: 30.07.2026 18:27

Manufacturer products View details

VEGA

VEGA-001

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

Manufacturer: Chengdu Seamaty Technology Co.,Ltd
Manufacturer SRN: CN-MF-000033937
UDI-DI: 06973947590009
Basic UDI-DI: 6973947590009GX
Reference: VEGA-001
EMDN: W02010499
EMDN description: BLOOD GAS ANALYSIS / ELECTROLYTE INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 22:46

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

Blood Gas Analyzer

Afresh H1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600398
Basic UDI-DI: 695441760308B1ZF
Reference: NA
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Netherlands
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 17.07.2026 23:48

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Blood Gas Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600404
Basic UDI-DI: 695441760308B1ZF
Reference: NA
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: -
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 17.07.2026 22:43

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RAPIDLab® Conditioner

IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RL1200/348EX_CP

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414194462
Basic UDI-DI: 0405686901922VZ
Reference: 10311078
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

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Luer Capillary

IVDR_69_TTN_DUB-C_A_NPT_BG-RapidLab1200

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414482361
Basic UDI-DI: 0405686901916W6
Reference: 10309073
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Deproteinizer

IVDR_69_TTN_DUB-C_A_NPT_REAG_BG-RL1200/348EX_CP

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414055909
Basic UDI-DI: 0405686901922VZ
Reference: 10309775
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

EasyLyte Neo Analyzer

IVD Class BIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Medica Corporation
Manufacturer SRN: US-MF-000037250
UDI-DI: 00379497005899
Basic UDI-DI: 0379497ELNAKClCaQL
Reference: 30030
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Greece
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

GEM Premier 7000 with iQM3

00000015279

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 00195226000924
Basic UDI-DI: 0195226000924R3
Reference: 00000015279
EMDN: W0201040102
EMDN description: BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 15.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA -TS2 Blood Gas Analyzer

OPTI CRITICAL CARE ANALYZER - TS2

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

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000732
Basic UDI-DI: 00894472GD704644
Reference: GD7046
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

OPTI CCA -TS Blood Gas Analyzer

OPTI CRITICAL CARE ANALYZER - TS (TOUCHSCREEN)

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

Manufacturer: OPTI Medical Systems, Inc.
Manufacturer SRN: US-MF-000027152
UDI-DI: 00894472000152
Basic UDI-DI: 00894472GD70133M
Reference: GD7013
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

NS Biotec electrolyte analyzer

EA-205

IVD generalIVDDNo longer on the marketInstrumentKit

Manufacturer: NS BIOTEC
Manufacturer SRN: EG-MF-000032515
UDI-DI: D-EG-MF-000032515KP
Basic UDI-DI: B-EG-MF-000032515KP
Reference: EA205
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EL (SE-1520)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47215H2
Basic UDI-DI: B-47215H2
Reference: 47215
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EL (SE-1520)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47214GY
Basic UDI-DI: B-47214GY
Reference: 47214
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EL (SE-1520)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47204GV
Basic UDI-DI: B-47204GV
Reference: 47204
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

16972337852205

BG3

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 16972337852205
Basic UDI-DI: B-16972337852205
Reference: BG3
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

16972337852199

BE3,ELE-I, ELE-Ⅱ, ELE-Ⅲ, BG3, BG7, BG8, BG9-Ⅰ, BG9-Ⅱ, BG10-Ⅰ, BG10-Ⅱ

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 16972337852199
Basic UDI-DI: B-16972337852199
Reference: BE3
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

16972337852182

BG7

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 16972337852182
Basic UDI-DI: B-16972337852182
Reference: BG7
EMDN: W0201040185
EMDN description: BLOOD GAS ANALYSERS - CONSUMABLES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

06972873820235

Vitagas 5E

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873820235
Basic UDI-DI: B-06972873820235
Reference: Vitagas 5E
EMDN: W0201040102
EMDN description: BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 16:09

Manufacturer products Authorised representative products Authorised representative actors View details