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DNA Fragmentation Quantification Assay

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830231
Basic UDI-DI: 506053683FQA001Y4
Reference: FQA-RT40
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Poland
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 22.09.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

VIRPLEX 8

VX8S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884776181
Basic UDI-DI: 697488477TLH020YT
Reference: VX8S
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 22.09.2026 02:58

Manufacturer products Authorised representative products Authorised representative actors View details

EMAG® v1.2 UPDATE INSTALLER DVD

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026608613
Basic UDI-DI: B-03573026608613
Reference: 423124
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 23:30

Manufacturer products View details

Accessory Box

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771102902
Basic UDI-DI: 8056771MOL1100TP
Reference: MOL1100
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 21.09.2026 21:38

Manufacturer products View details

Idylla™ Console

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219000126
Basic UDI-DI: 5415219P0010GM
Reference: P1010
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 21:00

Manufacturer products View details

Idylla™ Hub

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219001390
Basic UDI-DI: 5415219P0010GM
Reference: P1030
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 21:00

Manufacturer products View details

Idylla™ Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219000119
Basic UDI-DI: 5415219P0010GM
Reference: P0010
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 21.09.2026 21:00

Manufacturer products View details

Myriapod NGS Hereditary probe

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: DIATECH PHARMACOGENETICS SRL
Manufacturer SRN: IT-MF-000018670
UDI-DI: 08057289091313
Basic UDI-DI: 8057289090000ANG0397C
Reference: NG039
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Italy
Authorised representative: -
Last updated: 21.09.2026 20:47

Manufacturer products View details

FilmArray® Torch System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020253
Basic UDI-DI: 357302BUDI000922TZ
Reference: HTFA-ASY-0104
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 21.09.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

06973685471301

TINA107

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: 3D Biomedicine Science & Technology Co., Limited
Manufacturer SRN: CN-MF-000020934
UDI-DI: 06973685471301
Basic UDI-DI: B-06973685471301
Reference: 3000000000401
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.09.2026 17:53

Manufacturer products Authorised representative products Authorised representative actors View details

06973685471295

TINA102

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: 3D Biomedicine Science & Technology Co., Limited
Manufacturer SRN: CN-MF-000020934
UDI-DI: 06973685471295
Basic UDI-DI: B-06973685471295
Reference: 3000000000393
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.09.2026 17:53

Manufacturer products Authorised representative products Authorised representative actors View details

GINA Lyse 200

GINA 500

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730664
Basic UDI-DI: 912012773GINA7H
Reference: 09120127730664
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: -
Last updated: 12.08.2026 23:34

Manufacturer products View details

careHPV Test Luminometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228048015
Basic UDI-DI: 4053228ICARELUM0000000128
Reference: 9001773
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:47

Manufacturer products View details

RapiCycler 96 Real Time PCR System (4-Channel)

G2MRAPI4001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200087
Basic UDI-DI: 890617820G2MRAPI4001CV
Reference: G2MRAPI4001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

RapiCycler 96 Real Time PCR System-(6-Channel)

G2MRAPI4002

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200094
Basic UDI-DI: 890617820G2MRAPI4002CX
Reference: G2MRAPI4002
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850544
Basic UDI-DI: 69332898CE3186FW
Reference: WK50
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850575
Basic UDI-DI: 69332898CE3186FW
Reference: WK53
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

WonDx-1001, WonDx-1002, WonDx-1003, WonDx-1004, WonDx-1005, WonDx-1006, WonDx-1007, WonDx-1008, U-CardDx 200-1001, U-CardDx 200-1002, U-CardDx 200-1003, U-CardDx 200-1004,U-CardDx 200-1005,U-CardDx 200-1006, U-CardDx 200-1007,U-CardDx 200-1008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850568
Basic UDI-DI: 69332898CE3186FW
Reference: WK52
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850551
Basic UDI-DI: 69332898CE3186FW
Reference: WK51
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 06.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

06974795551013

Archimed X4

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551013
Basic UDI-DI: 6974795551001CA9
Reference: Archimed X4
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 06.08.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details