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45 device results listed.

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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

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

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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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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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

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

06933289817073

Ucare-6000

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

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289817073
Basic UDI-DI: 69332898CE1705FL
Reference: W924
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: QbD RepS BV
Last updated: 02.07.2026 09:56

Manufacturer products Authorised representative products Authorised representative actors View details

06933289811163

BGA-102

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

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289811163
Basic UDI-DI: 69332898CE1116ET
Reference: W957 W956
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: QbD RepS BV
Last updated: 02.07.2026 09:56

Manufacturer products Authorised representative products Authorised representative actors View details

06947929531151

Gaslite80A、Gaslite80B、Gaslite80、Gaslite80AQ、Gaslite80BQ、Gaslite80Q、Gaslite80E

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Meizhou Cornley Hi-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000025014
UDI-DI: 06947929531151
Basic UDI-DI: 69479295Gaslite80Z2
Reference: Gaslite80E
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: Caretechion GmbH
Last updated: 28.06.2026 02:28

Manufacturer products Authorised representative products Authorised representative actors View details

06947929500522

Gaslite80A、Gaslite80B、Gaslite80、Gaslite80AQ、Gaslite80BQ、Gaslite80Q、Gaslite80E

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Meizhou Cornley Hi-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000025014
UDI-DI: 06947929500522
Basic UDI-DI: 69479295Gaslite80Z2
Reference: Gaslite80Q
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: Caretechion GmbH
Last updated: 28.06.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

06947929500515

BG-800A、BG-800B、BG-800、BG-800AQ、BG-800BQ、BG-8000、BG-800E

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Meizhou Cornley Hi-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000025014
UDI-DI: 06947929500515
Basic UDI-DI: 69479295BG-800LB
Reference: BG-800Q
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: Caretechion GmbH
Last updated: 28.06.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

06947929500508

Gaslite80A、Gaslite80B、Gaslite80、Gaslite80AQ、Gaslite80BQ、Gaslite80Q、Gaslite80E

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Meizhou Cornley Hi-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000025014
UDI-DI: 06947929500508
Basic UDI-DI: 69479295Gaslite80Z2
Reference: Gaslite80BQ
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: Caretechion GmbH
Last updated: 28.06.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

06947929500492

BG-800A、BG-800B、BG-800、BG-800AQ、BG-800BQ、BG-8000、BG-800E

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Meizhou Cornley Hi-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000025014
UDI-DI: 06947929500492
Basic UDI-DI: 69479295BG-800LB
Reference: BG-800BQ
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: Caretechion GmbH
Last updated: 28.06.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details