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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

KEYU Feces Analyzer

Feces Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360019
Basic UDI-DI: 697473536KUA01P4
Reference: KU-F20
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
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

qLabs® ElectroMeter Plus

Q-2 Plus

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168135
Basic UDI-DI: 697470316Q-2PlusTN
Reference: Q-2 Plus
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
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® ElectroMeter

Q-1 Pro

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168128
Basic UDI-DI: 697470316Q-1ProHA
Reference: Q-1 Pro
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
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® ElectroMeter

Q-3 Plus

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168111
Basic UDI-DI: 697470316Q-3PlusTZ
Reference: Q-3 Plus
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® ElectroMeter

Q-3 Pro

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168104
Basic UDI-DI: 697470316Q-3ProHQ
Reference: Q-3 Pro
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

06974674895016

BAS-10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674895016
Basic UDI-DI: 697467489001659Z
Reference: 29-06-0003
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Biochemistry Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Taizhou Zecen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000050486
UDI-DI: 06976868801018
Basic UDI-DI: 697420115YQ003E5
Reference: NEO-1200
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Italy
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 15:42

Manufacturer products Authorised representative products Authorised representative actors View details

06973861681630

SHA-100, SHA-200

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861681630
Basic UDI-DI: 6973861681630F6
Reference: SHA-100, SHA-200
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

06973609151050

BC-600

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609151050
Basic UDI-DI: 697360915105KM
Reference: （01）6973609151050（11）210113（21）5A52021001
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

CLIA-mate 1200, CLIA-mate Plus

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: 06973356047224
Basic UDI-DI: 697335604A001BX
Reference: CLIA-mate 1200
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 14:31

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

06973316740196

Speedry Chem

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

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740196
Basic UDI-DI: 697331674DBA00029S
Reference: A311011
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

06973262864120

EXC200,EXC220

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262864120
Basic UDI-DI: 69732628600024ZL
Reference: 02-10-02-0003-00
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06941967242284

EXC460, EXC470

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242284
Basic UDI-DI: 6973262860014626
Reference: 0112804
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967205678

EXC400, EXC420

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967205678
Basic UDI-DI: 69732628600037ZV
Reference: 02-10-00-0005-00
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06972719603725

A6I

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719603725
Basic UDI-DI: 6972719600091BJ
Reference: A6I
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginitis Detection System

LTS-V400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 06972235844244
Basic UDI-DI: 697223584V400GZ
Reference: LTS-V400
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details