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CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE

HyCT16.01-25

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074300234
Basic UDI-DI: 805750743HYCTHN
Reference: HyCT16.01-25
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:48

Manufacturer products View details

bCUBE3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074300166
Basic UDI-DI: 805750743H0001XV
Reference: H0001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:48

Manufacturer products View details

bCUBE 2.0

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074300098
Basic UDI-DI: 805750743BCUBEA9
Reference: bCUBE 2.0
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:48

Manufacturer products View details

SOPHiA GENETICS™ Dx Universal Library Prep

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SOPHiA GENETICS SA
Manufacturer SRN: CH-MF-000025221
UDI-DI: 07622283013121
Basic UDI-DI: 7622283ULPDx7A
Reference: BX6002UNICMDL30
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: France
Authorised representative: SOPHiA GENETICS SAS
Last updated: 03.07.2026 06:08

Manufacturer products Authorised representative products Authorised representative actors View details

SOPHiA DDM Dx mode

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: SOPHiA GENETICS SA
Manufacturer SRN: CH-MF-000025221
UDI-DI: 07622283009681
Basic UDI-DI: 762228300110AE
Reference: DXMode
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: SOPHiA GENETICS SAS
Last updated: 03.07.2026 06:08

Manufacturer products Authorised representative products Authorised representative actors View details

07290020318008

PCR-AI-01

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: AZURE VAULT LTD
Manufacturer SRN: IL-MF-000047316
UDI-DI: 07290020318008
Basic UDI-DI: 7290020318AIB4
Reference: PCR-AI-01
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Purification System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bio-gener Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027988
UDI-DI: 16980047303009
Basic UDI-DI: 698004730300FQ
Reference: BGNA-32P
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 03.07.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

06979822870488

Digital PCR Reader

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Cellomics (Shenzhen) Limited
Manufacturer SRN: CN-MF-000028334
UDI-DI: 06979822870488
Basic UDI-DI: 697982287DRCP0001FL
Reference: DRCP0001
EMDN: W02050107
EMDN description: MICRO-ARRAY SCANNERS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 03.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

06979502241492

MagiCube 48

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06979502241492
Basic UDI-DI: 697950224MC1048CD
Reference: MC1048
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

06979502241485

ABT-24

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06979502241485
Basic UDI-DI: 697950224MP112401MV
Reference: MP112401
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

06979502241362

X-Poche 16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06979502241362
Basic UDI-DI: 697950224PCR1116016E
Reference: MP112401
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

Genomate

Genomate workstation

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genecast (Wuhan) Precision Diagnostic Co., Ltd.
Manufacturer SRN: CN-MF-000051330
UDI-DI: 06979343850020
Basic UDI-DI: 697934385010016Z
Reference: 0100101
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 03.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Sequencer G100-E

G100-E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BGI Hangzhou CycloneSEQ Technology Co., Ltd.
Manufacturer SRN: CN-MF-000051828
UDI-DI: 06979280450000
Basic UDI-DI: 697928045SEQXW
Reference: H900-000022
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

06979232310024

CP-II

IVD Class AIVDR 2017/746On the market

Manufacturer: Shanghai LeChen Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000051606
UDI-DI: 06979232310024
Basic UDI-DI: 697923231002KS
Reference: 06979232310024
EMDN: W02050104
EMDN description: KARYOTYPE PROCESSING AUTOMATED SYSTEMS
First on market country: Austria
Authorised representative: Everbiz GmbH
Last updated: 03.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

06979232310017

CP-II-32

IVD Class AIVDR 2017/746On the market

Manufacturer: Shanghai LeChen Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000051606
UDI-DI: 06979232310017
Basic UDI-DI: 697923231001KQ
Reference: 06979232310017
EMDN: W02050104
EMDN description: KARYOTYPE PROCESSING AUTOMATED SYSTEMS
First on market country: Austria
Authorised representative: Everbiz GmbH
Last updated: 03.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

06978704661121

Deep well plate

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Suzhou Acumen Biomedical Technology Co., LTD.
Manufacturer SRN: CN-MF-000038603
UDI-DI: 06978704661121
Basic UDI-DI: 6978704662200FM
Reference: 220001-1
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Portugal
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:55

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

Flash20

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739174200
Basic UDI-DI: 697773917080200023C
Reference: 08020002
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect Nano

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739174132
Basic UDI-DI: 697773917080200063L
Reference: 08020006
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Sweden
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

Flash10

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739174125
Basic UDI-DI: 697773917080200053J
Reference: 08020005
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

06977364170004

BHP9609

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: R&G Biotech Co., Ltd
Manufacturer SRN: CN-MF-000047000
UDI-DI: 06977364170004
Basic UDI-DI: 697736417MNAA001UH
Reference: BHP9609
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 22:29

Manufacturer products Authorised representative products Authorised representative actors View details