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495 device results listed.

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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: 31.07.2026 10:53

Manufacturer products View details

geneLEAD VIII

geneLEAD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869127009
Basic UDI-DI: 4987869geneLEAD8S
Reference: A2700
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

geneLEAD XXIV

geneLEAD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869122400
Basic UDI-DI: 4987869geneLEAD24UE
Reference: A2240
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

04899959024511

Real-Time qPCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QUANTIDX HONG KONG LIMITED
Manufacturer SRN: HK-MF-000023647
UDI-DI: 04899959024511
Basic UDI-DI: 489995902451SL
Reference: SimpiDx Q16
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Katsura Biological Coporation

S2R16B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Katsura Biological Corp
Manufacturer SRN: TW-MF-000044228
UDI-DI: 04719883180018
Basic UDI-DI: 471988318S2R16BGB
Reference: S2R16B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Kingsmead Service B.V.
Last updated: 31.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

DELBIO Automated Nucleic Acid Analysis System

Automated Nucleic Acid Analysis System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DELBIO INC.
Manufacturer SRN: TW-MF-000003400
UDI-DI: 04713072985019
Basic UDI-DI: 471307298G1QT
Reference: G1-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

DTprime II 4M1

DTprime II

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366453
Basic UDI-DI: 466001436DA04ZS
Reference: О-DTPRIMEII4M1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

DTstream 9L1

DTstream

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366323
Basic UDI-DI: 466001436DA03ZQ
Reference: O-DTstream9L1-A-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

Automated TRCR Real-time Monitor TRCReady-80

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185395259
Basic UDI-DI: 45601892100040037K
Reference: 0023950
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746No longer on 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: 30.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

FilmArray® 2.0 Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020031
Basic UDI-DI: 357302BUDI000020SG
Reference: FLM2-ASY-0001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 02:34

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: 06933289850506
Basic UDI-DI: 69332898CE3186FW
Reference: WK46
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

SpotFire®

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

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020369
Basic UDI-DI: 357302BUDI000917U8
Reference: FAST-ASY-0002
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

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: 06933289850513
Basic UDI-DI: 69332898CE3186FW
Reference: WK47
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

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: 06933289850520
Basic UDI-DI: 69332898CE3186FW
Reference: WK48
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

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: 06933289850537
Basic UDI-DI: 69332898CE3186FW
Reference: WK49
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746No longer on 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: 29.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746No longer on 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: 29.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

QIAsymphony Connect

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228049982
Basic UDI-DI: 4053228IQSC000000000001MF
Reference: 9003450
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 09:33

Manufacturer products View details

08885019710421

800705

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710421
Basic UDI-DI: 888501971800705WZ
Reference: 800705
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 23.07.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details