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Automated Digital PCR System

AD3207

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360037
Basic UDI-DI: 697557836020010001Y6
Reference: 1200889
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

Microfluidic Chip

V3.0

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360006
Basic UDI-DI: 697557836030010002YT
Reference: 3100053
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360800

FC-96B,FC-96BE,FC-96GE,FC-96D,FC-96G.FC-384G,FC-1536G,FC-48D,FC-48N,FC-48T

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360800
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-96G
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

In-situ Denaturation and Hybridization Processor

DH100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dartmon Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000019183
UDI-DI: 06927210914634
Basic UDI-DI: 697550352DH100SERGX
Reference: DH110
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

06975491760174

SEP-8、SEP-32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Sciarray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000038307
UDI-DI: 06975491760174
Basic UDI-DI: 697549176ADEAMIPM
Reference: SEP-8
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

06975491760150

SET-48、SET-96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Sciarray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000038307
UDI-DI: 06975491760150
Basic UDI-DI: 697549176ANAEAPIYC
Reference: SET-48
EMDN: W02050299
EMDN description: MICRO-ARRAY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

Thermal Cycler&Real-time PCR

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440065
Basic UDI-DI: 697548844PCR22T5
Reference: PCR-96A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
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

06975461700377

QuantReady K9600

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lifereal Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000019191
UDI-DI: 06975461700377
Basic UDI-DI: 697546170QuantReadyKZ
Reference: QuantReady K9600
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:05

Manufacturer products Authorised representative products Authorised representative actors View details

06975457020045

LifeReady 1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lifereal Biotechnology Co.,Ltd
Manufacturer SRN: CN-MF-000030319
UDI-DI: 06975457020045
Basic UDI-DI: 697545702LifeReadyNG
Reference: LifeReady 1000
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

Micro-Spectrophotometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bio-gener Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027988
UDI-DI: 16975412638008
Basic UDI-DI: 697541263UMSUR
Reference: BGNANO-601
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR system

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bio-gener Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027988
UDI-DI: 16975412631009
Basic UDI-DI: 697541263PCRSPB
Reference: Q9602
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Galaxy Nano

Galaxy

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447581013
Basic UDI-DI: 697544758GALAXYU9
Reference: 101-0022-02
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

06975409760012

Real-time qPCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou LongGene Scientific Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000024510
UDI-DI: 06975409760012
Basic UDI-DI: 6975409760005DD
Reference: Q2000A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Workstation

Gene+GIN16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou GenePlus Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000035774
UDI-DI: 06975352996049
Basic UDI-DI: 697535299G1600196
Reference: EB5001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Portugal
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Gene+Box Data Analysis and Management System

Gene+Box

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou GenePlus Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000035774
UDI-DI: 06975352996018
Basic UDI-DI: 697535299BOX001QB
Reference: ED5001
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Portugal
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 18:44

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System

GT-96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Anhui Wanyi Science and Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000039194
UDI-DI: 06975337671015
Basic UDI-DI: 697533767PCR001PH
Reference: 001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975330320026

AUTO-MAGec 32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou MiYin Biotechnology Co.,Ltd
Manufacturer SRN: CN-MF-000041649
UDI-DI: 06975330320026
Basic UDI-DI: 697533032MYNAPSSY
Reference: AUTO-MAGec 32
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

Pluslife Dock Pro 8

PM008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120172
Basic UDI-DI: 697532712PM008G5
Reference: PM008
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Norway
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

MiniDock Ultra

PM001 Ultra

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

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120639
Basic UDI-DI: 697532712PM001UFG
Reference: PM001 Ultra
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: PureCE B.V.
Last updated: 02.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

Mini Dock

PM001

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

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120066
Basic UDI-DI: 697532712PM001FP
Reference: PM001
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details