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269 device results listed.

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Fluorescence Immunochromatographic Analyzer

iTest F100 / iTest F101 / iTest F800 / iTest F2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Shenzhen Ukin Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000055688
UDI-DI: 06978669681004
Basic UDI-DI: 697866968iTestPU
Reference: iTest F100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

Microplate Reader

MPR Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780159
Basic UDI-DI: 697850778MPR10VE
Reference: IN0113
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

Bio-INSTANT

FIC-H3

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentKitProfessional testing

Manufacturer: Hangzhou ELIT Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000043511
UDI-DI: 06976667950054
Basic UDI-DI: 697666795FIC-H3TJ
Reference: FIC-H3
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630020

ICX MFA 768B

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630020
Basic UDI-DI: 697604363ICXD002Q6
Reference: 002
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630013

ICX MFA768A

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630013
Basic UDI-DI: 697604363ICXD001Q4
Reference: 001
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

Microplate Reader

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440225
Basic UDI-DI: 697548844MPR22UX
Reference: MPR-H200BC
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 19:07

Manufacturer products Authorised representative products Authorised representative actors View details

Macro & Micro-Test Fluorescence Reader

HWTS IF 100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366716
Basic UDI-DI: 697484936W0201020201DG
Reference: HWTS-EQ005
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

ST-360 Microplate Reader

ST-360, ST-380, ST-960, ST-980

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Kehua Laboratory System Co., Ltd.
Manufacturer SRN: CN-MF-000017428
UDI-DI: 06974847812505
Basic UDI-DI: 697484781005Q8
Reference: ST-360
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Fluorescent Immunoassay Analyzer

FI-650S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361481
Basic UDI-DI: 697473536KUA09PL
Reference: FI-650S
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

Uni-medica Fluorescent Immunoanalyzer

Automatic Nucleic Acid System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Uni-medica Technology Co., Ltd.
Manufacturer SRN: CN-MF-000022946
UDI-DI: 06974561521332
Basic UDI-DI: 697456152UM-IF1003K
Reference: UM-IF 100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:29

Manufacturer products Authorised representative products Authorised representative actors View details

HC-10 Portable Colloidal Gold Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473303712
Basic UDI-DI: 697447330HC10HD
Reference: HC10
EMDN: W0201020280
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 16:16

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal Gold Reader

GIA100

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: 06974404980043
Basic UDI-DI: 697440498gia3A
Reference: GIA100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 15:57

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150190

DM 801B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150190
Basic UDI-DI: 697360915019KT
Reference: （01）6973609150190（11）210518（21）5C12021002
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Romania
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

Dry Fluorescence Immunoassay Analyzer

FIC-H1W、FIC-H1N、FIC-Q100、FIC-Q100N、FIC-H2、FIC-S100、FIC-A1600、FIC-M6、FIC-M6G、FIC-H0、FIC-H0mini、FIC-M2、FIC-M2NT

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

Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN: CN-MF-000002230
UDI-DI: 06973602150012
Basic UDI-DI: 697360215FICNY
Reference: FIC-H1W
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunochromatography Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200185
Basic UDI-DI: 69732628600036ZT
Reference: 02-11-03-0001-00
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

DX-Reader

DX-C1

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: 06972736230881
Basic UDI-DI: 697273623088LK
Reference: DX-C1
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

06971792050099

Fully Automatic Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792050099
Basic UDI-DI: 697179205CF7
Reference: RL-C2000
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

Microplate Reader

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977726
Basic UDI-DI: 69449040MYYQ-0104******89
Reference: MR-96T
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

On Call MultiPro Analyzer

OGM-221

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756496337
Basic UDI-DI: 6921756499990003WT
Reference: G116-112-201
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

NS Reader

5420100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172530010
Basic UDI-DI: 6438172532I0001RG
Reference: 5420100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

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