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217 device results listed.

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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 MAX (AX-4030)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-14506FS
Basic UDI-DI: B-14506FS
Reference: 14506
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 08:08

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AUTION MAX (AX-4030)

IVD generalIVDDNo longer on the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-14504FN
Basic UDI-DI: B-14504FN
Reference: 14504
EMDN: W020101020103
EMDN description: 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)

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)

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)

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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AUTION MAX (AX-4060)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105885NH
Basic UDI-DI: B-105885NH
Reference: 105885
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Poland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

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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)

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)

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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AUTION MAX (AX-4030)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102674MD
Basic UDI-DI: B-102674MD
Reference: 102674
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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AUTION MAX (AX-4060)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100528LK
Basic UDI-DI: B-100528LK
Reference: 100528
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

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AUTION MAX (AX-4060)

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100525LD
Basic UDI-DI: B-100525LD
Reference: 100525
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Romania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

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06978100260003

V-1

IVD generalIVDDOn the market

Manufacturer: Hivis Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000046009
UDI-DI: 06978100260003
Basic UDI-DI: B-06978100260003
Reference: V-1
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 01:38

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06976625190003

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Xiamen Vangenes Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000046896
UDI-DI: 06976625190003
Basic UDI-DI: B-06976625190003
Reference: V1
EMDN: W020101020192
EMDN description: AUTOMATED URINE ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:54

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KEYU Automatic Urine Analysis System

KU-3000

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361917
Basic UDI-DI: B-06974735361917
Reference: KU-3000
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

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KEYU Automatic Urine Analysis System

KU-2800

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360002
Basic UDI-DI: B-06974735360002
Reference: KU-2800
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:32

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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

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Urochroma™

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010556
Basic UDI-DI: 880613301055C3
Reference: FPRR062
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

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17290017272402

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