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105 device results listed.

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CarePak 110 Cartridge

POCBGCT005

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906294
Basic UDI-DI: 8806712POCBGCT0052B
Reference: POCBGCT005-50T2W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: Greece
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

POCBGCT001

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906140
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-30T2W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: France
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

CarePak 108 Cartridge

POCBGCT004

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906249
Basic UDI-DI: 8806712POCBGCT00429
Reference: POCBGCT004-50T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:44

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i-Smart 30 PRO Cartridge

POCECT003

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906058
Basic UDI-DI: 8806712POCECT003GX
Reference: POCECT003-50T4W
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 30 PRO Cartridge E4

POCECT004

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906102
Basic UDI-DI: 8806712POCECT004GZ
Reference: POCECT004-50T4W
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 30 Cartridge E5

POCECT002

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712905976
Basic UDI-DI: 8806712POCECT002GV
Reference: POCECT002-50T2W
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Lithuania
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 30 Cartridge

POCECT001

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712905907
Basic UDI-DI: 8806712POCECT001GT
Reference: POCECT001-50T2W
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Lithuania
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 Electrolyte Quality Control

POCEQC001

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712905723
Basic UDI-DI: 8806712POCEQC001HW
Reference: POCEQC001
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Romania
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-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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

CareSens Air Receiver

Receiver

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712010274
Basic UDI-DI: 8806712CGMR001T5
Reference: CGM-R-001
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
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

A1Care Analyzer

POCSPAL001

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712009902
Basic UDI-DI: 8806712POCSPAL001CB
Reference: POCSPAL001
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:43

Manufacturer products Authorised representative products Authorised representative actors View details

CareSens Air Continuous Glucose Monitoring System

Continuous Glucose Monitoring System

Class IIbMDR 2017/745On the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005980
Basic UDI-DI: 8806712CGM001PS
Reference: CGM-ST-002
EMDN: Z1204011501
EMDN description: NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS
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

CareSens Air app

Continuous Glucose Monitoring System App

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005096
Basic UDI-DI: 8806712CGMUA001Y4
Reference: HS-MA-11, HS-WA-01
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
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

Sens365

Glucose Data Management Software

Class IIbMDR 2017/745On the marketActive device

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712004518
Basic UDI-DI: 8806712CGMDM001UV
Reference: HS-MI-01, HS-WI-11
EMDN: Z1204011599
EMDN description: BLOOD SUGAR MONITORING SYSTEMS - OTHER
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

alphacheck professional Lancing Device

Lancing Device

Class IMDR 2017/745On the market

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 04260413710231
Basic UDI-DI: 8806712LC001SF
Reference: -
EMDN: -
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906157
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-30T3W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

i-Smart 300 Cartridge

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712906164
Basic UDI-DI: 8806712POCBGCT00123
Reference: POCBGCT001-50T2W
EMDN: W0101060610
EMDN description: BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details