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681 device results listed.

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Nucleic Acid Isothermal Amplification Detection Analyzer

BG-Nova-X8

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690403
Basic UDI-DI: 6974677690403J5
Reference: /
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:12

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Purification Instrument

BG-Flex-32

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690397
Basic UDI-DI: 6974677690397K3
Reference: /
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:12

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Automatic Nucleic Acid Purification Instrument

BG-Star-96

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690342
Basic UDI-DI: 6974677690342JA
Reference: /
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:12

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Ikoniscope20 Low Volume

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Ikonisys, Inc.
Manufacturer SRN: US-MF-000031487
UDI-DI: 08600079335168
Basic UDI-DI: 0860007933516UD
Reference: IK20LV
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:56

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Van Gogh Microscopy System

VGMS-01-EU

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

Manufacturer: CellTivity Scientific, Inc.
Manufacturer SRN: US-MF-000050094
UDI-DI: 00860012995301
Basic UDI-DI: 08600129953VGMS-01E7
Reference: VGMS-01
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:54

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Ikoniscope20 High Volume

20-160

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Ikonisys, Inc.
Manufacturer SRN: US-MF-000031487
UDI-DI: 00860007933523
Basic UDI-DI: 0860007933523UA
Reference: Ikoniscope 20 160
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:52

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Antigen Retrieval Chamber High Voltage

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627035509
Basic UDI-DI: 08476270BARCLN
Reference: DCARC0003
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Aucheer MW-01 Test cartridge incubator

MW-01

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038081
UDI-DI: 06974546541546
Basic UDI-DI: 0697454654MMW01CE
Reference: MMW01
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 16.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Aucheer YH-061 Test cartridge incubator

YH-061

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.
Manufacturer SRN: CN-MF-000038081
UDI-DI: 06974546541263
Basic UDI-DI: 0697454654LYH61CW
Reference: LYH61
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 16.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Cryofixator

Cryofixator & Accessories

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: X-ZELL Biotech Pte. Ltd.
Manufacturer SRN: SG-MF-000039227
UDI-DI: ++G580XZELLCryofixatorBXK1
Basic UDI-DI: ++G580XZELLCryofixatorBXK
Reference: XZ1022
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: X-ZELL Biotech GmbH
Last updated: 15.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

1312562TYP16.C072

Osmometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Axel Löser Messtechnik
Manufacturer SRN: DE-MF-000023401
UDI-DI: 1312562TYP16.C072
Basic UDI-DI: PP12562OSMOMETER42
Reference: TYP16.C
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:41

Manufacturer products View details

FluoBolt™ - Metal Enhanced Fluorescence (MEF) Analytics Platform

FluoBolt™- MEF Analytics Plattform

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: FIANOSTICS GmbH
Manufacturer SRN: AT-MF-000025705
UDI-DI: 111875634285
Basic UDI-DI: PP10748W0201029962
Reference: FIA-1700
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 14:38

Manufacturer products View details

VitaScreen

IVD generalIVDDOn the marketInstrument

Manufacturer: Noxygen Science Transfer & Diagnostics GmbH
Manufacturer SRN: DE-MF-000024761
UDI-DI: D-VitaScreenJL
Basic UDI-DI: B-VitaScreenJL
Reference: VitaScreen
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 13:28

Manufacturer products View details

Biomarker Analysis Platform

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Nightingale Health Oyj
Manufacturer SRN: FI-MF-000021253
UDI-DI: D-NGH-01026Z
Basic UDI-DI: B-NGH-01026Z
Reference: NGH-0102
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 14.07.2026 05:22

Manufacturer products View details

Bio Logbook - Healthcare

IVD generalIVDDOn the market

Manufacturer: BIO LOGBOOK
Manufacturer SRN: FR-MF-000053556
UDI-DI: D-FR-MF-0000535565D
Basic UDI-DI: B-FR-MF-0000535565D
Reference: Bio Logbook - Healthcare
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 21:43

Manufacturer products View details

DiagMMR

IVD generalIVDDNo longer on the marketHuman tissues

Manufacturer: Lynsight Oy
Manufacturer SRN: FI-MF-000024862
UDI-DI: D-FI-MF-000024862QP
Basic UDI-DI: B-FI-MF-000024862QP
Reference: 6489
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:28

Manufacturer products View details

ThEA RapiDx

RapiDx

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: RAM THz Solutions GmbH
Manufacturer SRN: DE-MF-000023978
UDI-DI: D-DEMF0000239784000RD7R
Basic UDI-DI: B-DEMF0000239784000RD7R
Reference: 4000RapiDx
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 13.07.2026 17:07

Manufacturer products View details

08683420315019

CompactOne 9

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Hemonart Medikal Sistemler Sanayi Ticaret A.Ş
Manufacturer SRN: TR-MF-000024210
UDI-DI: 08683420315019
Basic UDI-DI: B-08683420315019
Reference: CompactOne 9
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 09.07.2026 00:05

Manufacturer products View details

08594221360019

Lipidica 1.0

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Lipidica, a.s.
Manufacturer SRN: CZ-MF-000040652
UDI-DI: 08594221360019
Basic UDI-DI: B-08594221360019
Reference: Lipidica 1.0
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:51

Manufacturer products View details

Helicobacter Pylori Analyzer

FR-9202

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Badiusen Biotechnology (Kunshan) Co., Ltd
Manufacturer SRN: CN-MF-000032909
UDI-DI: 06976093859228
Basic UDI-DI: B-06976093859228
Reference: FR-9202
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Denmark
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details