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

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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

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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

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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

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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

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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

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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

AXINON® System

AXINON System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: numares AG
Manufacturer SRN: DE-MF-000022282
UDI-DI: 04260539610217
Basic UDI-DI: 426053961AX0700X5
Reference: AX0700
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:10

Manufacturer products View details

AXINON® Software

AXINON Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: numares AG
Manufacturer SRN: DE-MF-000022282
UDI-DI: 04260539610194
Basic UDI-DI: 426053961AX0402WS
Reference: AX0402
EMDN: W0201010192
EMDN description: CHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:10

Manufacturer products View details

Selectra ProM

6003-404

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VitalScientific B.V.
Manufacturer SRN: NL-MF-000021018
UDI-DI: 03701700860396
Basic UDI-DI: 37017008ProM-SeriesSL
Reference: 6003-435
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: -
Last updated: 30.07.2026 21:52

Manufacturer products View details

Selectra Mach5

6004-301

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VitalScientific B.V.
Manufacturer SRN: NL-MF-000021018
UDI-DI: 03701700860549
Basic UDI-DI: 37017008Mach-seriesPP
Reference: 6004-301
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: -
Last updated: 30.07.2026 21:52

Manufacturer products View details

Selectra ProS

6003-500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VitalScientific B.V.
Manufacturer SRN: NL-MF-000021018
UDI-DI: 03701700860327
Basic UDI-DI: 37017008ProS-SeriesW6
Reference: 6003-500
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: -
Last updated: 30.07.2026 21:52

Manufacturer products View details

Pentra C200 Standard

Pentra C200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006689
Basic UDI-DI: 361023pentra_c2006U
Reference: 1280090005
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

Pentra C400 ISE

Pentra C400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006559
Basic UDI-DI: 361023pentra_c40076
Reference: 1280241013
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

Pentra C200 ISE

Pentra C200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006672
Basic UDI-DI: 361023pentra_c2006U
Reference: 1280090002
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Pentra C400 Standard

Pentra C400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006542
Basic UDI-DI: 361023pentra_c40076
Reference: 1280241012
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

MICROPLATE TYPE P4 (12PCS/SET)

ZM062100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 04987666528559
Basic UDI-DI: 150995901ZM062100GD
Reference: ZM062100
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

CA-310

Clinical Chemistry Analyzer CA-310 without ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Furuno Electric Co., Ltd.
Manufacturer SRN: JP-MF-000026828
UDI-DI: 04560161906918
Basic UDI-DI: 0456016CA-310-NOISE9D
Reference: CA000002750
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 30.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details