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06975569870002

CAS60 CAS70 CAS80 CAS90

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Sinseng Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000024231
UDI-DI: 06975569870002
Basic UDI-DI: 697556987SSCAS45
Reference: CAS60
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 19:17

Manufacturer products Authorised representative products Authorised representative actors View details

Vivadiag

LP-101/LP-102

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

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519630663
Basic UDI-DI: 6975519630001B5C
Reference: LC-103-1/LC-113-1
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 19:14

Manufacturer products Authorised representative products Authorised representative actors View details

Semi-automatic Biochemistry Analyzer

SMT-70A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Co., Ltd.
Manufacturer SRN: CN-MF-000033945
UDI-DI: 06975347780523
Basic UDI-DI: 6975347780523FH
Reference: AWGBZDFXY-0002
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 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Semi-automatic Biochemistry Analyzer

SMT-70

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Co., Ltd.
Manufacturer SRN: CN-MF-000033945
UDI-DI: 06975347780028
Basic UDI-DI: 6975347780028F2
Reference: AWGBZDFXY-0001
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 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemistry Analyzer

SMT-10A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Co., Ltd.
Manufacturer SRN: CN-MF-000033945
UDI-DI: 06975347780011
Basic UDI-DI: 6975347780011EH
Reference: AWGSMT10A001
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 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

06975239780013

One Minute Drug Analyzer

IVD Class AIVDR 2017/746On the market

Manufacturer: Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000020377
UDI-DI: 06975239780013
Basic UDI-DI: 697523978OMDATT
Reference: IVDR
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 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

06975239780006

Fluorescence immunoassay analyzer

IVD Class AIVDR 2017/746On the market

Manufacturer: Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000020377
UDI-DI: 06975239780006
Basic UDI-DI: 697523978FIAV3
Reference: IVDR
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 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemistry Analyzer

MS-420P,MS-400P,MS-380P,MS-420,MS-400,MS-380,MS-480,MS-450,MS-520,MS-600,MS-680

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ningbo MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014369
UDI-DI: 06975096610058
Basic UDI-DI: 697509661MSC001P5
Reference: MS380P
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Türkiye
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

06974950600051

Y-30/Y-348/Y-80/B-48/B-80/Y-30B/Y-48/Y-80B/B-48B/M-30/M-40/M-80/M-90/m-100

Class IMDR 2017/745On the market

Manufacturer: Guangzhou Yunrui Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000020374
UDI-DI: 06974950600051
Basic UDI-DI: 697495060000033C
Reference: MDR
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 17:46

Manufacturer products Authorised representative products Authorised representative actors View details

Landwind

LW C80 LW C50

IVD Class AIVDR 2017/746Not intended for EU marketHuman tissuesInstrumentProfessional testing

Manufacturer: Shenzhen Landwind Biomedical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000026781
UDI-DI: 06974890940231
Basic UDI-DI: 697489094LWD004W6
Reference: 023
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

ZY-400 Automatic Clinical Chemistry Analyzer

ZY-400, ZY-450, ZY-460, ZY-480, Polaris c1000, Polaris c1100, Polaris c2000, Polaris c2100, ZY-680, ZY-690, ZY-1200, ZY-1250, ZY-1260, ZY-1280, G9800, ZY-260, ZY-280

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Kehua Laboratory System Co., Ltd.
Manufacturer SRN: CN-MF-000017428
UDI-DI: 06974847810013
Basic UDI-DI: 697484781001PY
Reference: ZY-400
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:35

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

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