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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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19.09.2026 17:27

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80 device results listed.

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DCA Vantage Analyzer (Professional Use)

IVDR_69_TTN_DUB-C_A_NPT_INST_DCA-ACR

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414551371
Basic UDI-DI: 0405686901932W4
Reference: 10282970
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 22:57

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PocketChem UA (PU-4010)

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20707FM
Basic UDI-DI: B-20707FM
Reference: 20707
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem UA (PU-4010)

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20705FH
Basic UDI-DI: B-20705FH
Reference: 20705
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:38

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PocketChem UA (PU-4010)

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-20704FF
Basic UDI-DI: B-20704FF
Reference: 20704
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 14:28

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AUTION ELEVEN (AE-4020)

AUTION ELEVEN (AE-4020)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-14440FM
Basic UDI-DI: B-14440FM
Reference: 14440
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 08:08

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AUTION ELEVEN (AE-4020)

AUTION ELEVEN (AE-4020)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-14405FK
Basic UDI-DI: B-14405FK
Reference: 14405
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 08:08

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AutionIDaten (AE-4070)

AutionIDaten (AE-4070)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-108203MC
Basic UDI-DI: B-108203MC
Reference: 108203
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 03:38

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PocketChem UA (PU-4010)

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102678MM
Basic UDI-DI: B-102678MM
Reference: 102678
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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PocketChem UA (PU-4010)

PocketChem UA (PU-4010)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102677MK
Basic UDI-DI: B-102677MK
Reference: 102677
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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AUTION ELEVEN (AE-4020)

AUTION ELEVEN (AE-4020)

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102676MH
Basic UDI-DI: B-102676MH
Reference: 102676
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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-

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000047634
UDI-DI: 04897146460029
Basic UDI-DI: 489714646MR001JA
Reference: HT-115A
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Hungary
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 05.07.2026 19:37

Manufacturer products Authorised representative products Authorised representative actors View details

Minuteful - kidney test

IVD Class CIVDR 2017/746Not intended for EU marketDirect markingNear-patient testingSelf testingSingle use

Manufacturer: Healthy.io
Manufacturer SRN: IL-MF-000023029
UDI-DI: 17290017272402
Basic UDI-DI: 729001727240AT
Reference: MNT KDN.EN.GEN
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: -
Safety summary (SSCP/SSP): MNT-KT-EU-SSP-01 · Rev. 2
Authorised representative: AR Experts B.V.
Last updated: 03.07.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Urine Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440034
Basic UDI-DI: 697548844UA22S3
Reference: UA-SA-200
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE 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

Semi-Automatic Urine Analyzer

U 350; U 370; U 390

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168355466
Basic UDI-DI: 6972168352202A5
Reference: EHU9101004
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Türkiye
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

URIT-31、UC-32A、UC-32B、URIT-50、URIT-180、URIT-330、URIT-500、URIT-500C、URIT-560、UC-58、UC-280A、UC-280B、UC-600A、UC-50A、UC-50B、UC-50C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740722018
Basic UDI-DI: 69357407IUC000002WV
Reference: /
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

HCU01, HCU02

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000016839
UDI-DI: 06934822535232
Basic UDI-DI: 693482255700J5
Reference: HCU01
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

Quik-Check Expert U120 Smart Urine Analyzer

Expert U120 Smart Urine Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756496436
Basic UDI-DI: 6921756499990025X5
Reference: U118-101-201
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

Mission U120 Smart Urine Analyzer

U120 Smart Urine Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756496412
Basic UDI-DI: 6921756499990023WZ
Reference: U117-101-201
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

Quik-Check Expert U500 Urine Analyzer

Expert U500 Urine Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756496399
Basic UDI-DI: 6921756499990026X7
Reference: U213-107-201
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

Mission U500 Urine Analyzer

U500 Urine Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756496351
Basic UDI-DI: 6921756499990024X3
Reference: U211-101-201
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details