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

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997 device results listed.

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RX daytona plus (with ISE)

RX daytona plus

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273207774
Basic UDI-DI: 50552732ADAYPLU015HS
Reference: RX4040
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

RX monaco

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273207750
Basic UDI-DI: 50552732AMONACO037GJ
Reference: RX5000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

ACID WASH SOLUTION (AWS)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273206982
Basic UDI-DI: 50552732AAWSOLN001P8
Reference: WS3853
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

RX imola

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273206104
Basic UDI-DI: 50552732ARXIMOL025WX
Reference: RX4900
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

C1 Solution (C1 SOLN)

C1 SOLUTION (C1 SOLN)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273206074
Basic UDI-DI: 50552732AC1SOLN00937
Reference: RX3973
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

RX WASH CONCENTRATE (WASH conc. 3)

RX WASH CONCENTRATE (WASH conc.)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273205947
Basic UDI-DI: 50552732AWASCON008NK
Reference: RX3946
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

JCA-BM6070/C

BM Family

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: JEOL Ltd. MF
Manufacturer SRN: JP-MF-000026608
UDI-DI: 04987762049088
Basic UDI-DI: 4987762B04900KK
Reference: CA-20241BM607C
EMDN: W0201010108
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)
First on market country: Netherlands
Authorised representative: JEOL(Europe)BV AR
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

SpotChem D-Concept 2e (SD-4840)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486047216
Basic UDI-DI: 4987486BC0110046F9
Reference: 110046
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

SpotChem D-Concept 2c (SD-4830)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486047186
Basic UDI-DI: 4987486BC0110044F5
Reference: 110044
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

SPOTCHEM EZ (SP-4430)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486034551
Basic UDI-DI: 4987486BC0107501GJ
Reference: 107501
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

The Lab 004 (DB-3910)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486028659
Basic UDI-DI: 4987486BC0105581GU
Reference: 105581
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

AA01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Otsuka Electronics Co., Ltd.
Manufacturer SRN: JP-MF-000001943
UDI-DI: 04987274142079
Basic UDI-DI: 4987274W0201010101A01EW
Reference: 04987274142079
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

NS-Prime

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Otsuka Electronics Co., Ltd.
Manufacturer SRN: JP-MF-000001943
UDI-DI: 04987274142093
Basic UDI-DI: 4987274W0201010101PRMN2
Reference: 04987274142093
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000047634
UDI-DI: 04897146460104
Basic UDI-DI: 489714646MR003JE
Reference: HTSH-2000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Hungary
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 31.07.2026 07:18

Manufacturer products Authorised representative products Authorised representative actors View details

BIOLIS 30i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biolis Medical Corp.
Manufacturer SRN: JP-MF-000025468
UDI-DI: 04580262016002
Basic UDI-DI: 458026201BIOLIS30i2W
Reference: 60-01-0001
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 06:14

Manufacturer products Authorised representative products Authorised representative actors View details

Alkaline Washing Solution

Washing Solution

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Biolis Medical Corp.
Manufacturer SRN: JP-MF-000025468
UDI-DI: 04580262010208
Basic UDI-DI: 458026201WSTE
Reference: SP2208
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 06:14

Manufacturer products Authorised representative products Authorised representative actors View details

FUJI PLAIN TUBE

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04902520282774
Basic UDI-DI: 454741030100000000000436U
Reference: 04902520282774
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 06:04

Manufacturer products Authorised representative products Authorised representative actors View details

FUJI DRI-CHEM CLEAN TIPS

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04902520282514
Basic UDI-DI: 4547410301000000000003873
Reference: 04902520282514
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 06:04

Manufacturer products Authorised representative products Authorised representative actors View details

FUJI DRI-CHEM MIXING CUPS

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410071696
Basic UDI-DI: 4547410301000000000003975
Reference: 04547410071696
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

FUJI DRI-CHEM AUTO TIPS

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 04547410033144
Basic UDI-DI: 454741030100000000000376Z
Reference: 04547410033144
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 31.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details