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216 device results listed.

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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

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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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i-Smart 30 PRO Electrolyte Analyzer

POCEAL002

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712900926
Basic UDI-DI: 8806712POCEAL002EF
Reference: POCEAL002
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:43

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i-Smart 30 Electrolyte Analyzer

POCEAL001

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712900896
Basic UDI-DI: 8806712POCEAL001ED
Reference: POCEAL001
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:43

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CFΔ Collection System

UCF2011

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000196
Basic UDI-DI: 86992260UCF2011TW
Reference: UCF2011
EMDN: W0201040203
EMDN description: CHLORIDE ANALYSERS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

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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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Diestro

Electrolyte Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: JS Medicina Electrónica SRL
Manufacturer SRN: AR-MF-000024519
UDI-DI: 07798387250073
Basic UDI-DI: 838725ANISEET
Reference: EQ 0790
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 12:47

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POCT Electrolyte Analyzer

SE1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020365
Basic UDI-DI: 6978848020365HM
Reference: A00811000EN0
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

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 Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020143
Basic UDI-DI: 6978848020143GZ
Reference: A00810000EN0
EMDN: W02010499
EMDN description: BLOOD GAS ANALYSIS / ELECTROLYTE INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

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Electrolyte Analyzer

EA Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780210
Basic UDI-DI: 697850778ELA10P5
Reference: IN0124
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

Electrolyte Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440270
Basic UDI-DI: 697548844EA22NK
Reference: EA-7-25-A
EMDN: W0201040201
EMDN description: ION SELECTIVE ELECTROLYTE ANALYSERS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 19:07

Manufacturer products Authorised representative products Authorised representative actors View details