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104 device results listed.

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TruOx

TX100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763815
Basic UDI-DI: 5065023763TX100VT
Reference: TX10001
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

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

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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

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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

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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

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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

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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

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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

i-SmartCare 10 Blood Gas Analyzer

POCBGAL002

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712901152
Basic UDI-DI: 8806712POCBGAL002XL
Reference: POCBGAL002
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:43

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Blood Gas Analyzer

POCBGAL001

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712901091
Basic UDI-DI: 8806712POCBGAL001XJ
Reference: POCBGAL001
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:43

Manufacturer products Authorised representative products Authorised representative actors View details

GEM Premier ChemSTAT

00044000000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426951293865
Basic UDI-DI: 84269512938659Z
Reference: 00044000000
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: 03.07.2026 13:14

Manufacturer products Authorised representative products Authorised representative actors View details

GEM Premier 3500 (Refurbished)

00026000000R

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950947363
Basic UDI-DI: 8426950947363AK
Reference: 00026000000R
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: 03.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

2D BARCODE GUN

00025000420

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950915706
Basic UDI-DI: 84269509157069C
Reference: 00025000420
EMDN: W0201040180
EMDN description: BLOOD GAS ANALYSERS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

Wireless Barcode Scanner, 2D

00025000400

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950915690
Basic UDI-DI: 84269509156909N
Reference: 00025000400
EMDN: W0201040180
EMDN description: BLOOD GAS ANALYSERS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details