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707 device results listed.

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Fluorescence immunoassay analyzer

IF208/IF201/IF101

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

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198481038
Basic UDI-DI: 69781984802001A4
Reference: 2103
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic fluorescence microscopic image scanning analyzer

GK-IMG1000 / GK-IMG3000 / GK-IMG5000

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: 06977698400433
Basic UDI-DI: 697769840GKPD07976
Reference: GKPD079
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
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

Fluorescence Biological Microscope

GK-23M、GK-33M、GK-500DM、GK-750DM

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: 06977698400426
Basic UDI-DI: 697769840GKPD00467
Reference: GKPD004
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
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

Fully-Automatic fluorescence microscopic Images scanning and analysis system

GK-IMG8000、GK-IMG8100、GK-IMG8200

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: 06977698400419
Basic UDI-DI: 697769840GKPD0806P
Reference: GKPD080
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
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

Automated Stainer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Naturn Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000042263
UDI-DI: 06977568270012
Basic UDI-DI: 697756827AS7G
Reference: ST1010
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter Pylori Detector System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hunan Celis Biotech Co., Limited
Manufacturer SRN: CN-MF-000042425
UDI-DI: 06977562100018
Basic UDI-DI: 697756210HPDSQQ
Reference: SUBT-D1
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

06977430041023

WinCyto

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Winmedic Tech Co., Ltd.
Manufacturer SRN: CN-MF-000041945
UDI-DI: 06977430041023
Basic UDI-DI: 697743004WinCyto52
Reference: WinCyto
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

06977430041016

WinSlideLib

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Winmedic Tech Co., Ltd.
Manufacturer SRN: CN-MF-000041945
UDI-DI: 06977430041016
Basic UDI-DI: 697743004WinSlideLibPZ
Reference: WinSlideLib
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

06977430041009

WinTele

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Winmedic Tech Co., Ltd.
Manufacturer SRN: CN-MF-000041945
UDI-DI: 06977430041009
Basic UDI-DI: 697743004WinTele49
Reference: WinTele
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

06977430040002

Science/Win20/Win60/Win180/HS480/SMART/Win-RD-Pro/Win-RD-Pro-S/Win-40-Pro/Win-40-Pro-S/Win-ED-Pro/Win-ED-Pro-S/Win-120-Pro/Win-120-Pro-S/Win-CD-Pro/Win-CD-Pro-S/Win-300-Pro/Win-300-Pro-S

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Winmedic Tech Co., Ltd.
Manufacturer SRN: CN-MF-000041945
UDI-DI: 06977430040002
Basic UDI-DI: 697743004WMDPSSVW
Reference: Science
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

Microplate Washer

WHY100T, WHY100ST, WHYM200, WHYM300

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Poweam Medical Co., Ltd
Manufacturer SRN: CN-MF-000040207
UDI-DI: 06977226450459
Basic UDI-DI: 697722645BTMW01RY
Reference: WHY100T
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
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

Microplate Reader

WHY101S, WHY101ST, WHYM201, WHYM301

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Poweam Medical Co., Ltd
Manufacturer SRN: CN-MF-000040207
UDI-DI: 06977226450411
Basic UDI-DI: 697722645BTMR01R7
Reference: WHY101S
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
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

HbA1c Analyzer

TH6000，THX6000，TH7000A，TH7000B

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Nanjing Poweam Medical Co., Ltd
Manufacturer SRN: CN-MF-000040207
UDI-DI: 06977226450268
Basic UDI-DI: 697722645BTHA02MH
Reference: TH6000
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
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

Biochemistry Analyzer

WHY5000D, WHY5000B, WHY8000D, WHY8000D VET, WHY6000D, WHY7000D, D-06, D-B6, D-C6, D-D6, A6, B6, C6, WHYA7, WHYA8

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Nanjing Poweam Medical Co., Ltd
Manufacturer SRN: CN-MF-000040207
UDI-DI: 06977226450114
Basic UDI-DI: 697722645BTBA01L5
Reference: WHY5000D
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
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

06977221990066

HB-1000E, HB-900E, HB-500E, HB-300E, HB-150E, HB-100E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiaxing CRED Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000041285
UDI-DI: 06977221990066
Basic UDI-DI: 697722199IMMUNOSORBENTY2
Reference: HB-100E
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Sequencer

UniSeq2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu ME Instruments Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041672
UDI-DI: 06977211570018
Basic UDI-DI: 697721157UniSeq2000KG
Reference: UniSeq2000
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

06976832920004

TSP-201 TSP-301 TSP-302 QB-200A QB-200B QB-200C QB-300A QB-300B QB-300C QB-400A QB-400B QB-400C QA-1 QA-2 QA-3 TSP-202 TSP-206

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Xuzhou Qibo Electronic Technology Co.,Ltd
Manufacturer SRN: CN-MF-000038310
UDI-DI: 06976832920004
Basic UDI-DI: 697683292QBASA012U
Reference: TSP-201
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details

06975912300033

TB-1M

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DeepMega Intelligent Technology Co., Ltd.
Manufacturer SRN: CN-MF-000048350
UDI-DI: 06975912300033
Basic UDI-DI: 697591230DSS001K9
Reference: TB-1M
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

06975598030842

Plastic nasal speculum

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Jiangsu Yuli Medical Instrument Co.,Ltd
Manufacturer SRN: CN-MF-000038669
UDI-DI: 06975598030842
Basic UDI-DI: 697559803NS01SF
Reference: Plastic nasal speculum
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 19:20

Manufacturer products Authorised representative products Authorised representative actors View details

Microvolume UV/Vis (Nano)/Nucleic Acid Analyzer

Spectrophotometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440430
Basic UDI-DI: 697548844SP22TY
Reference: SP-MUV2000
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 19:08

Manufacturer products Authorised representative products Authorised representative actors View details