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SEEPREP32™

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240109021
Basic UDI-DI: 924010SG71100KB
Reference: SG71100
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Seegene NIMBUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240109014
Basic UDI-DI: 9240106541503V8
Reference: 65415-03
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

LQ Suite Droplet Generator

TGR-100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BioTNS Co., Ltd.
Manufacturer SRN: KR-MF-000026409
UDI-DI: 08800271570002
Basic UDI-DI: 8800271578800271570002BW
Reference: TGR-100
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Advena Limited
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Preparation Workstation（LS450）

LS450、PCore

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Legend-Tec Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047100
UDI-DI: 06977357002190
Basic UDI-DI: 697735700219MM
Reference: LGSW001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: GRZAN GROUP SL
Last updated: 16.07.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

LTS-AS96

LTS-AS96、 LTS-AS96A、 LTS-AS30

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 06972235844060
Basic UDI-DI: 697223584ASZE
Reference: LTS-AS96
EMDN: W02069001
EMDN description: AUTOSAMPLERS
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 11:01

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Z 207 H

Non-refrigerated Centrifuges

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Hermle Labortechnik GmbH
Manufacturer SRN: DE-MF-000024779
UDI-DI: 04262380371446
Basic UDI-DI: 4262380371AB11ABJW
Reference: 331.00 P01
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:21

Manufacturer products View details

Centrifuge Micro 230V FC5513+R02 IVD

FRONTIER

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Hermle Labortechnik GmbH
Manufacturer SRN: DE-MF-000024779
UDI-DI: 04262380370869
Basic UDI-DI: 4262380371AD11ADKQ
Reference: 83041569
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:21

Manufacturer products View details

Sigma 4-5KL

Sigma laboratory centrifuge IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Sigma Laborzentrifugen GmbH
Manufacturer SRN: DE-MF-000009414
UDI-DI: 04260734390051
Basic UDI-DI: 426073439IVD01001JQCJ4
Reference: 100007
EMDN: W02069005
EMDN description: REFRIGERATED CENTRIFUGES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:20

Manufacturer products View details

08800080220013

ACS-101

Class IMDR 2017/745On the market

Manufacturer: BSL CO. LTD.
Manufacturer SRN: KR-MF-000025426
UDI-DI: 08800080220013
Basic UDI-DI: 088000802ACS-CV8
Reference: 08800080220013
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 07:05

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Procleix Xpress System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Grifols Diagnostic Solutions Inc.
Manufacturer SRN: US-MF-000004304
UDI-DI: 00866489000005
Basic UDI-DI: 08664890000Xpress001YG
Reference: 718431
EMDN: W02060180
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 16.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

00860009458109

Sentinel

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrument

Manufacturer: VistaPath Biosystems, Inc.
Manufacturer SRN: US-MF-000039863
UDI-DI: 00860009458109
Basic UDI-DI: 08600094581173
Reference: Sentinel V1
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 06:52

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QBC Capillary Centrifuge

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Drucker Diagnostics
Manufacturer SRN: US-MF-000031517
UDI-DI: 00858092006031
Basic UDI-DI: 0858092006DDCCXZ
Reference: 425740
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:42

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Thermo Scientific Medifuge

Medifuge

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Thermo Electron LED GmbH Zweigniederlassung Osterode
Manufacturer SRN: DE-MF-000008786
UDI-DI: 10850685007972
Basic UDI-DI: 0850685007750088_IVD5N
Reference: 75008800
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 06:36

Manufacturer products View details

Thermo Scientific MT 17 IVD-MD

Microliter

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Thermo Electron LED GmbH Zweigniederlassung Osterode
Manufacturer SRN: DE-MF-000008786
UDI-DI: 10850044310262
Basic UDI-DI: 0850685007750024_IVDZR
Reference: 75002577
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 06:36

Manufacturer products View details

Thermo Scientific C1TR IVD-MD

MISTT

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Thermo Electron LED GmbH Zweigniederlassung Osterode
Manufacturer SRN: DE-MF-000008786
UDI-DI: 10850044310040
Basic UDI-DI: 0850685007750072_IVD37
Reference: 75009103
EMDN: W02069005
EMDN description: REFRIGERATED CENTRIFUGES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 06:36

Manufacturer products View details

Thermo Scientific Multifuge X4 Pro-MD

GP4 Pro

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Thermo Electron LED GmbH Zweigniederlassung Osterode
Manufacturer SRN: DE-MF-000008786
UDI-DI: 10850033408161
Basic UDI-DI: 0850685007750095_IVD52
Reference: 75009500
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 06:36

Manufacturer products View details

Thermo Scientific SL1 Plus-MD

GP1 Pro

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Thermo Electron LED GmbH Zweigniederlassung Osterode
Manufacturer SRN: DE-MF-000008786
UDI-DI: 10850033408017
Basic UDI-DI: 0850685007750092_IVD3Z
Reference: 75009000
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 06:36

Manufacturer products View details

Maxwell® CSC XtractAll FFPE DNA/RNA Kit

AS1560

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Promega Corporation
Manufacturer SRN: US-MF-000034520
UDI-DI: 00849811083778
Basic UDI-DI: 08498110837784W
Reference: AS1560
EMDN: W02060185
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

Maxwell® CSC Rapid ccfDNA Kit

AS1580

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Promega Corporation
Manufacturer SRN: US-MF-000034520
UDI-DI: 00849811081835
Basic UDI-DI: 084981108183543
Reference: AS1580
EMDN: W02060185
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

Maxwell® CSC Pathogen Total Nucleic Acid Kit

AS1860

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Promega Corporation
Manufacturer SRN: US-MF-000034520
UDI-DI: 00849811069062
Basic UDI-DI: 08498110690623Y
Reference: AS1860
EMDN: W02060185
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details