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107 device results listed.

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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

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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

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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

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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

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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

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GEM Premier 5000

00024019255

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950870227
Basic UDI-DI: 84269508702279D
Reference: 00024019255
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 13:12

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Corded 2D Barcode Imager

00024015859

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950869634
Basic UDI-DI: 8426950869634BJ
Reference: 00024015859
EMDN: W0201040180
EMDN description: BLOOD GAS ANALYSERS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:12

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GEM Premier 3500

00026000000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950793328
Basic UDI-DI: 8426950793328AJ
Reference: 00026000000
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 13:12

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Blood Gas Analyzer

BGA Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780203
Basic UDI-DI: 697850778BGA10LZ
Reference: IN0125
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

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Electrolyte Analyzer

EL-1100, EL-1100PLUS, EL-1200, EL-2200, EL-2300

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Poweam Medical Co., Ltd
Manufacturer SRN: CN-MF-000040207
UDI-DI: 06977226450305
Basic UDI-DI: 697722645BTEA01LS
Reference: EL-1100
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:23

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Coagulation Analyzer

MC100

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838800587
Basic UDI-DI: 697583880MC100MB
Reference: HE10004
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: Sungo Cert GmbH
Last updated: 02.07.2026 20:09

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Blood Gas Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440058
Basic UDI-DI: 697548844BGA22LJ
Reference: BGA-150-3
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 19:07

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POCT Electrolyte Analyzer

SE1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Co., Ltd.
Manufacturer SRN: CN-MF-000033945
UDI-DI: 06975347780141
Basic UDI-DI: 6975347780141EX
Reference: A00811000EN0
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Blood gas & Electrolyte Analyzer

SG1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Co., Ltd.
Manufacturer SRN: CN-MF-000033945
UDI-DI: 06975347780059
Basic UDI-DI: 6975347780059FD
Reference: A00810000EN0
EMDN: W0201040101
EMDN description: BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

06975022535004

Blood Gas Analyzer

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

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: 06975022535004
Basic UDI-DI: 69750225320111CEJ7
Reference: EN102
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: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:54

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Hemo Oxygen Parameter Analyzer

HOPA

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873822710
Basic UDI-DI: 697287382HOPASU
Reference: The model number is consistent with the catalogue number
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: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Gas Electrolyte Analyzer

BG5000F 、Vitagas5F

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873822697
Basic UDI-DI: 697287382BGV5FPM
Reference: The model number is consistent with the catalogue number
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: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Gas Electrolyte Analyzer

BG9000

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873822536
Basic UDI-DI: 697287382BG9000EJ
Reference: The model number is consistent with the catalogue number
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: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Gas Electrolyte Analyzer

BG5000E、BG5000、BG5000B、BG5000A、Vitagas 5E、Vitagas 5 Vitagas 5B、Vitagas 5A

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873821812
Basic UDI-DI: 697287382BG5000EF8
Reference: The model number is consistent with the catalogue number
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: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Gas Electrolyte Analyzer

Vitagas8E、BG-800A、BG-800B、BG-800、BG-800AQ、BG-800BQ、BG-800Q

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873820013
Basic UDI-DI: 697287382Vitagas8EB6
Reference: The model number is consistent with the catalogue number
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: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 13:18

Manufacturer products Authorised representative products Authorised representative actors View details