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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 00:16

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21 device results listed.

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FUJI DRI-CHEM SLIDE Na-K-Cl

FUJI DRI-CHEM SLIDE Na-K-Cl

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410447873
Basic UDI-DI: B-04547410447873
Reference: 04547410447873
EMDN: W01010803
EMDN description: MULTIPLE ELECTROLYTES ONLY - ELECTRODES/BIOSENSORS
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 25.07.2026 12:10

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FUJI DRI-CHEM SLIDE Na-K-Cl

FUJI DRI-CHEM SLIDE Na-K-Cl

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410032987
Basic UDI-DI: B-04547410032987
Reference: 04547410032987
EMDN: W01010803
EMDN description: MULTIPLE ELECTROLYTES ONLY - ELECTRODES/BIOSENSORS
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 25.07.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors View details

Kinesia ONE

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Great Lakes NeuroTechnologies Inc
Manufacturer SRN: US-MF-000031444
UDI-DI: 00859584006003
Basic UDI-DI: 0859584006KinesiaWG
Reference: Kinesia ONE 700-0019
EMDN: W01010899
EMDN description: MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER
First on market country: Bulgaria
Authorised representative: AF Pharma Service Europe SL
Last updated: 16.07.2026 06:49

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SPOTCHEM D Electrolyte (Na, K, Cl)

SPOTCHEM D Electrolyte (Na, K, Cl)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77963KH
Basic UDI-DI: B-77963KH
Reference: 77963
EMDN: W01010803
EMDN description: MULTIPLE ELECTROLYTES ONLY - ELECTRODES/BIOSENSORS
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:25

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SPOTCHEM E-Plate

SPOTCHEM E-Plate

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77083JA
Basic UDI-DI: B-77083JA
Reference: 77083
EMDN: W01010803
EMDN description: MULTIPLE ELECTROLYTES ONLY - ELECTRODES/BIOSENSORS
First on market country: Finland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:19

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MulticareIN Starter Kit - ITA

MulticareIN Multiparameter device

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937234120
Basic UDI-DI: B-08032937234120
Reference: 3830005IT
EMDN: W01010805
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - ELECTRODES/BIOSENSORS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 11:57

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MulticareIN (Glucose Test Strips) Kit - HU

MulticareIN Multiparameter device

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937233840
Basic UDI-DI: B-08032937233840
Reference: 3830001HU
EMDN: W01010805
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - ELECTRODES/BIOSENSORS
First on market country: Hungary
Authorised representative: -
Last updated: 07.07.2026 11:57

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MulticareIN (Cholesterol Test Strips) Kit - RO

MulticareIN Multiparameter device

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937233666
Basic UDI-DI: B-08032937233666
Reference: 3830003RO
EMDN: W01010805
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - ELECTRODES/BIOSENSORS
First on market country: Romania
Authorised representative: -
Last updated: 07.07.2026 11:57

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MulticareIN (Cholesterol Test Strips) Kit - GRK

MulticareIN Multiparameter device

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937232874
Basic UDI-DI: B-08032937232874
Reference: 3830003GR
EMDN: W01010805
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - ELECTRODES/BIOSENSORS
First on market country: Greece
Authorised representative: -
Last updated: 07.07.2026 11:56

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MulticareIN (Cholesterol Test Strips + Lancind Device) Kit - ENG

MulticareIN Multiparameter device

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937232812
Basic UDI-DI: B-08032937232812
Reference: 3830003 EP
EMDN: W01010805
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - ELECTRODES/BIOSENSORS
First on market country: France
Authorised representative: -
Last updated: 07.07.2026 11:56

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MulicareIN Starter Kit - ENG

MulticareIN Multiparameter device

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937232676
Basic UDI-DI: B-08032937232676
Reference: 3830005
EMDN: W01010805
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - ELECTRODES/BIOSENSORS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:56

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MulticareIN (Cholesterol Test Strips) Kit - ENG

MulticareIN Multiparameter device

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937232591
Basic UDI-DI: B-08032937232591
Reference: 3830003 E
EMDN: W01010805
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - ELECTRODES/BIOSENSORS
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 11:56

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MulticareIN (Glucose Test Strips) Kit - ENG

MulticareIN Multiparameter device

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937231624
Basic UDI-DI: B-08032937231624
Reference: 3830001E
EMDN: W01010805
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - ELECTRODES/BIOSENSORS
First on market country: France
Authorised representative: -
Last updated: 07.07.2026 11:56

Manufacturer products View details

MulticareIN (Cholesterol Test Strips) Kit - ITA

MulticareIN Multiparameter device

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937231259
Basic UDI-DI: B-08032937231259
Reference: 3830003IT
EMDN: W01010805
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - ELECTRODES/BIOSENSORS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 11:56

Manufacturer products View details

BSA-E00182

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446080131
Basic UDI-DI: 880944608BSX0X0PL
Reference: BSA-E00182
EMDN: W01010899
EMDN description: MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

Multi Biosensor Module

CBS-300, cbs-400, KS-401

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337850136
Basic UDI-DI: 697233785MBM008HX
Reference: 90101
EMDN: W01010803
EMDN description: MULTIPLE ELECTROLYTES ONLY - ELECTRODES/BIOSENSORS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Great Lakes NeuroTechnologies Inc
Manufacturer SRN: US-MF-000031444
UDI-DI: 00859584006034
Basic UDI-DI: 0859584006KinesiaWG
Reference: Kinesia One 700-0019-1
EMDN: W01010899
EMDN description: MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER
First on market country: -
Authorised representative: AF Pharma Service Europe SL
Last updated: 21.06.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Great Lakes NeuroTechnologies Inc
Manufacturer SRN: US-MF-000031444
UDI-DI: 00859584006058
Basic UDI-DI: 0859584006KinesiaWG
Reference: Kinesia 360 700-0019-2
EMDN: W01010899
EMDN description: MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER
First on market country: -
Authorised representative: AF Pharma Service Europe SL
Last updated: 21.06.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Great Lakes NeuroTechnologies Inc
Manufacturer SRN: US-MF-000031444
UDI-DI: 00859584006096
Basic UDI-DI: 0859584006KinesiaWG
Reference: Kinesia U 700-0025
EMDN: W01010899
EMDN description: MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER
First on market country: -
Authorised representative: AF Pharma Service Europe SL
Last updated: 21.06.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Great Lakes NeuroTechnologies Inc
Manufacturer SRN: US-MF-000031444
UDI-DI: 00859584006102
Basic UDI-DI: 0859584006KinesiaWG
Reference: Kinesia U - 700-0026
EMDN: W01010899
EMDN description: MULTIPLE PARAMETER - ELECTRODES/BIOSENSORS - OTHER
First on market country: -
Authorised representative: AF Pharma Service Europe SL
Last updated: 21.06.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details