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199 device results listed.

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Sediment Analyzer

KU-600A

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735362242
Basic UDI-DI: B-06974735362242
Reference: KU-600A
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Sediment Analyzer

KU-2000

IVD generalIVDDOn the marketInstrument

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735362235
Basic UDI-DI: B-06974735362235
Reference: KU-2000
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Sediment Analyzer

UM-30

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735362228
Basic UDI-DI: B-06974735362228
Reference: UM-30
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU All-in-One Analyzer

Fusion Scan™ FU30

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735362211
Basic UDI-DI: B-06974735362211
Reference: Fusion Scan™ FU30
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Sediment Analyzer

KU-600

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360033
Basic UDI-DI: B-06974735360033
Reference: KU-600
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

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

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: 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

LordsMed Urine Analyser

LM006

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470051
Basic UDI-DI: 890619447LM006F9
Reference: LM006
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

08800026300229

Exdia PT10

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

Manufacturer: Precision Biosensor Inc.
Manufacturer SRN: KR-MF-000034861
UDI-DI: 08800026300229
Basic UDI-DI: 88000263PDPT10FQ
Reference: PD-PT10
EMDN: W0201010299
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - OTHER
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 03.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

SENTiFIT® 800 Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SENTINEL CH. S.p.A.
Manufacturer SRN: IT-MF-000012556
UDI-DI: 08058056684806
Basic UDI-DI: 805805668CIS80003I1226ANV
Reference: 550802
EMDN: W0201010299
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:53

Manufacturer products View details

08050247770022

MSAT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: H & D S.R.L.
Manufacturer SRN: IT-MF-000036620
UDI-DI: 08050247770022
Basic UDI-DI: 805024777MSATE4
Reference: MSAT
EMDN: W0201010299
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:32

Manufacturer products View details

08050247770015

FRASB

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: H & D S.R.L.
Manufacturer SRN: IT-MF-000036620
UDI-DI: 08050247770015
Basic UDI-DI: 805024777FRASB9S
Reference: FRASB
EMDN: W0201010299
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:32

Manufacturer products View details

08050247770008

IFRAS5

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

Manufacturer: H & D S.R.L.
Manufacturer SRN: IT-MF-000036620
UDI-DI: 08050247770008
Basic UDI-DI: 805024777FRAS592
Reference: IFRAS5
EMDN: W0201010299
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:32

Manufacturer products View details