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ISCUS flex Microdialysis Analyzer

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentMicrobial substancesNear-patient testingProfessional testing

Manufacturer: M Dialysis AB
Manufacturer SRN: SE-MF-000017466
UDI-DI: 07332699000607
Basic UDI-DI: 7332699_300_001_UZ
Reference: 8003295
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:09

Manufacturer products View details

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

Auto Dry Biochemistry Analyzer

SD1080

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020372
Basic UDI-DI: 6978848020372HJ
Reference: A00814000EN0
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: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Dry Biochemistry Analyzer

SD3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020266
Basic UDI-DI: 6978848020266HJ
Reference: A00813000EN0
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: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Dry Biochemistry Analyzer

SD1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020044
Basic UDI-DI: 6978848020044GW
Reference: A00812000EN0
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: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

SMT-120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020020
Basic UDI-DI: 6978848020020GG
Reference: A00815000EN0
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: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Biochemical Analyzer

UKCA 2000 / UKCA 3000 / UKCA 6500 / UKCA 8800

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Shenzhen Ukin Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000055688
UDI-DI: 06978669682209
Basic UDI-DI: 697866968UKCA3S
Reference: UKCA 2000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors 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

Biochemistry Analyzer

BA Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780029
Basic UDI-DI: 697850778BIA10MF
Reference: IN0122
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
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

06978189070050

JIE-100

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

Manufacturer: Yantai JIEZI Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000044146
UDI-DI: 06978189070050
Basic UDI-DI: 697818907JZCHAWG
Reference: JIE-100
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

06978151030006

CH-12，CH-24 FA-160，FA-200，FA-300，FA-400，FA-600，FA-800 SA-20，SA-30，SA-30A，SA-30C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CLINDIAG SYSTEMS CO., LTD
Manufacturer SRN: CN-MF-000043506
UDI-DI: 06978151030006
Basic UDI-DI: 697815103KLDBAJT
Reference: CH-12
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic Multi-functional Analyzer

C3-E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chongqing Juce Life Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000053774
UDI-DI: 06977981880256
Basic UDI-DI: 697798188025Y
Reference: C3-E
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

Dry Fluorescence Immunoassay Analyzer

GKYG-500、GKYG-600、GKYG-800、GKYG-1000、GKYG-2000、GKYG-3000

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

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: 06977698401003
Basic UDI-DI: 697769840GKPD0166E
Reference: GKPD016
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer ACCENT-400

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514601707
Basic UDI-DI: 59075146Accent400SS
Reference: B08-A0002
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:41

Manufacturer products 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

TECOM

TC6090L, TC6030L, TC220, TC200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Tecom Science Corporation
Manufacturer SRN: CN-MF-000038772
UDI-DI: 06977149630006
Basic UDI-DI: 697714963TKACATK
Reference: TC6090L
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

PINNACLES KunLun Automatic Chemistry Analyzer

KunLun c2800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Pinnacles (Suzhou) Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000039051
UDI-DI: 06976960820009
Basic UDI-DI: 697696082KL7A
Reference: /
EMDN: W0201010108
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975838802529

MU500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838802529
Basic UDI-DI: 697583880MS003QU
Reference: HE10015
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 20:09

Manufacturer products Authorised representative products Authorised representative actors View details