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111 device results listed.

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mLabs® Smart

m-20

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168098
Basic UDI-DI: 697470316m-20LF
Reference: m-20
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY 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

mLabs® ImmunoMeter

m-101

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168081
Basic UDI-DI: 697470316m-101HS
Reference: m-101
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY 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

Fully Automatic ELISA Analyzer

ME-1000、ME-2000Pro、ME-4000Pro ME-4800、ME-4800Plus、ME-4800Pro、ME-8000、ME-8000Plus、ME-8000Pro 、ME-8400、ME-8400Plus、ME-8400Pro、 ME-8800、ME-8800D、ME-8800DPlus、ME-8800DPro、ME-8800L、ME-8800LPlus、ME-8800LPro etc.

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changsha Imadek Intelligent Technology Co., Ltd.
Manufacturer SRN: CN-MF-000042852
UDI-DI: 06974312710008
Basic UDI-DI: 697431271MEYU
Reference: ME-1000
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 15:50

Manufacturer products Authorised representative products Authorised representative actors View details

Anbio Biotechnology

AF-100, AF-100S, AF-100C, AF-1200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Anbio Biotechnology Limited
Manufacturer SRN: CN-MF-000042849
UDI-DI: 06973861682552
Basic UDI-DI: 6973861682552FJ
Reference: AF-100
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

Anbio

AF-100, AF-100S, AF-100C, AF-1200

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

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861681715
Basic UDI-DI: 6973861681647FP
Reference: AF-1200
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

06973597100085

Wan200+

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

Manufacturer: Xiamen United Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000028165
UDI-DI: 06973597100085
Basic UDI-DI: 697359710Wan200+GK
Reference: Wan200+ S
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

06973597100078

Wan100

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

Manufacturer: Xiamen United Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000028165
UDI-DI: 06973597100078
Basic UDI-DI: 697359710Wan1006J
Reference: Wan100
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Immunoblot Instrument

DX-Blot 45Ⅱ

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Zheda Dixun Biological Gene Engineering Co.,Ltd.
Manufacturer SRN: CN-MF-000028711
UDI-DI: 06972736230898
Basic UDI-DI: 697273623089LM
Reference: DX-Blot 45Ⅱ
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 13:09

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic IHC Staining System

CNT360-MP1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06978497293387
Basic UDI-DI: 697180456CNT360PQ9
Reference: CNT360-MP2
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 12:19

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic Immunohistochemistry Stainer

CNT330Plus

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06978497293370
Basic UDI-DI: 697180456CNT330PPS
Reference: CNT330Plus
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 12:19

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic Immunohistochemistry Stainer

CNT300Plus

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06978497293363
Basic UDI-DI: 697180456CNT300PPB
Reference: CNT300Plus
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 12:19

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic Special Stainer and Coverslipper

CNT520

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804563173
Basic UDI-DI: 697180456CNT520HK
Reference: CNT520
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic IHC Stainer

CNT320

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804562015
Basic UDI-DI: 697180456CNT320H9
Reference: CNT320
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

Dry-type Immunofluorescence Quantitative Analyzer

MF-T1000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760045
Basic UDI-DI: 697134876001A0045UH
Reference: MF-01
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 11:49

Manufacturer products Authorised representative products Authorised representative actors View details

Time resolved Fluoroimmunoassay Analyzer

FIA Go

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152492
Basic UDI-DI: 697122593GS48014AL7
Reference: FIA Go
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Analyzer

Aristo

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225933180
Basic UDI-DI: 697122593GS5672805TG
Reference: Aristo
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Analyzer

Nephstar Plus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225933111
Basic UDI-DI: 697122593GS5672802TA
Reference: Nephstar Plus
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Analyzer

Nephstar

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225931759
Basic UDI-DI: 697122593GS5672801T8
Reference: Nephstar
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Analyzer

Omlipo

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225931605
Basic UDI-DI: 697122593GS5672803TC
Reference: Omlipo
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

Specific Protein Analyzer

GPP-100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930004
Basic UDI-DI: 697122593GS5672810T9
Reference: GPP-100
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details