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AURA 10 PET-CT

Model A

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

Manufacturer: XEOS Medical
Manufacturer SRN: BE-MF-000033451
UDI-DI: 05430002734026
Basic UDI-DI: 5430002734AURA10PET/CTMV
Reference: XHW-100340
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:09

Manufacturer products View details

DYONMED iFIA-1000

DYONMED AXCEED P200

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251202016
Basic UDI-DI: 520025120DNMDEVMICR0001RU
Reference: DNHYDV2
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:28

Manufacturer products View details

DYONMED AXCEED P200

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251202009
Basic UDI-DI: 520025120DNMDEVMICR0001RU
Reference: DNBSDV1
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:25

Manufacturer products View details

POConePlus-AS10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Otsuka Electronics Co., Ltd.
Manufacturer SRN: JP-MF-000001943
UDI-DI: 04987035301615
Basic UDI-DI: 498703502AS460644BJ
Reference: 03530161
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

POConePlus Infrared Spectrophotometer

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Otsuka Electronics Co., Ltd.
Manufacturer SRN: JP-MF-000001943
UDI-DI: 04987035301516
Basic UDI-DI: 498703502XX460644TU
Reference: 03530151
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

04897036920251

92025

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920251
Basic UDI-DI: 489703692920254T
Reference: 92025
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 07:13

Manufacturer products Authorised representative products Authorised representative actors View details

Magnetite

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SIA Laboveritas
Manufacturer SRN: LV-MF-000018225
UDI-DI: 04751042630019
Basic UDI-DI: 475104263070102BH
Reference: 070102
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Latvia
Authorised representative: -
Last updated: 31.07.2026 06:58

Manufacturer products View details

Igloo Reader Pro

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Dx365 GmbH
Manufacturer SRN: DE-MF-000038389
UDI-DI: 04262479180034
Basic UDI-DI: 426247918R-DAAN
Reference: R-DA
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:39

Manufacturer products View details

Trimtec

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: SLEE medical GmbH
Manufacturer SRN: DE-MF-000041949
UDI-DI: 04260248680457
Basic UDI-DI: 4260248680440WH
Reference: 10190001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:49

Manufacturer products View details

Staintec Mini

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SLEE medical GmbH
Manufacturer SRN: DE-MF-000041949
UDI-DI: 04260248680433
Basic UDI-DI: 4260248680426WP
Reference: 17005000
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:49

Manufacturer products View details

FluoVista System

FluoVista

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483922
Basic UDI-DI: 426015248FV140WC
Reference: 006 010 000
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:31

Manufacturer products View details

04099466360519

Seramun SpotSight well

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466360519
Basic UDI-DI: 4099466SPWELLAX
Reference: SP-WELL-A
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:26

Manufacturer products View details

04099466360113

Seramun SpotSight plate mono

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466360113
Basic UDI-DI: 4099466SPPLATEEZ
Reference: SP-PLATE-C
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:26

Manufacturer products View details

04099466350015

Seramun SpotSight® scan

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466350015
Basic UDI-DI: 4099466SPSCAN8U
Reference: SP-SCAN-A
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:26

Manufacturer products View details

CellTracks AutoPrep System

9541

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Menarini Silicon Biosystems, Inc
Manufacturer SRN: US-MF-000042008
UDI-DI: 10888385000061
Basic UDI-DI: B-10888385000061
Reference: 9541
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Menarini Silicon Biosystems S.p.A.
Last updated: 30.07.2026 02:26

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Sequencing Library Preparation System GenSIRO-48

MGIFLP-L, GenSIRO-16

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318133481
Basic UDI-DI: 697431813MGIFLPN2
Reference: GenSIRO-48
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.07.2026 14:01

Manufacturer products Authorised representative products Authorised representative actors View details

06970895479547

Automatic Nucleic Acid Extractor (MLN96)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895479547
Basic UDI-DI: 697089547ANAE04NN
Reference: MLN96T105
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 29.07.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

06970895479530

Automatic nucleic acid extractor (MLN32)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895479530
Basic UDI-DI: 697089547ANAE03NL
Reference: MLN32T102
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: SUNGO Europe B.V.
Last updated: 29.07.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

CellTracks Analyzer II

9555R

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Menarini Silicon Biosystems, Inc
Manufacturer SRN: US-MF-000042008
UDI-DI: 10888385000627
Basic UDI-DI: B-10888385000627
Reference: 9555R
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Menarini Silicon Biosystems S.p.A.
Last updated: 28.07.2026 11:30

Manufacturer products Authorised representative products Authorised representative actors View details

Thermobrite

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832002079
Basic UDI-DI: 849832026UX
Reference: 3800-004852-001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 28.07.2026 01:21

Manufacturer products Authorised representative products Authorised representative actors View details