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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

Urine Sediment Analyzer

UA Series, Evo Series, USA Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780227
Basic UDI-DI: 697850778USE10WS
Reference: IN0129
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

UA Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780166
Basic UDI-DI: 697850778UAE10SU
Reference: IN0128
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

Aolun Clini-Lab80Pro

Clini-Lab80Pro，Clini-Lab100Pro，3 Clini-Lab500Pro

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Chongqing Aolun Technology Co., Ltd.
Manufacturer SRN: CN-MF-000046602
UDI-DI: 06978291020011
Basic UDI-DI: 697829101W0201010201VF
Reference: 10081
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

WHY120FA, WHY130FA, WHY140FA, WHY160FA, WHY170FA&WHY160FA, WHY170FA

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Poweam Medical Co., Ltd
Manufacturer SRN: CN-MF-000040207
UDI-DI: 06977226450350
Basic UDI-DI: 697722645BTUA01QA
Reference: WHY120FA
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Sediment Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440577
Basic UDI-DI: 697548844USA22VP
Reference: Evo-S50
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors 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

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Automatic Urine Analyzer

BH-QNY series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shandong Bohong Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000025971
UDI-DI: 06974901972367
Basic UDI-DI: 69749019723QNY**J2
Reference: BH-QNY02
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 17:43

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

BH-NY01, BH-NY01S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shandong Bohong Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000025971
UDI-DI: 06974901972190
Basic UDI-DI: 6974901972*NY***8K
Reference: BH-NY01
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 17:42

Manufacturer products Authorised representative products Authorised representative actors View details

Landwind

LW C100Plus 、LW C100、LW C200T、LW C200E、 LW C400、 LW C360、LW C420、LW C480、LW C600、LW C800

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentProfessional testingSingle use

Manufacturer: Shenzhen Landwind Biomedical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000026781
UDI-DI: 06974890940170
Basic UDI-DI: 697489094LWD001VY
Reference: 017
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Dry Chemistry Urine Analyzer

Dry Chemistry Urine Analyzer

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360026
Basic UDI-DI: 697473536KUA03P8
Reference: KU-500
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® eStation II

MBI92

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168159
Basic UDI-DI: 697470316MBI92HD
Reference: MBI92
EMDN: W0201010280
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® eStation

MBI91-1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168142
Basic UDI-DI: 697470316MBI91-1J7
Reference: MBI91-1
EMDN: W0201010280
EMDN description: LIMITED PANEL CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

06973316740264

Speedry UR

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

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740264
Basic UDI-DI: 697331674UA000001FS
Reference: A511011
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 14:30

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

Automatic Urinalysis System

U 2000, U 2000S

IVD Class BIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168352106
Basic UDI-DI: 6972168352201A3
Reference: EHU9101007
EMDN: W020101020103
EMDN description: 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

06935740735360

UD-2300

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740735360
Basic UDI-DI: 69357407IUD000002XE
Reference: /
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Maintenance agent for Urine Analyzer

URIT D 22

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740731928
Basic UDI-DI: 69357407IUCS000004QS
Reference: U6040022N
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740723541

URIT D 21N、URIT D 22

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740723541
Basic UDI-DI: 69357407IUCS000003QQ
Reference: /
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740723435

US-1680、US-500、US-1000

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740723435
Basic UDI-DI: 69357407IUS0000017E
Reference: /
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details