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MAST ISOPLEX® E. coli O157

DNA/LYO4

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Mast Group Limited
Manufacturer SRN: GB-MF-000025209
UDI-DI: 15056152705333
Basic UDI-DI: 50561527LYO4NN
Reference: DNA/LYO4
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Mast Diagnostica GmbH
Last updated: 02.07.2026 01:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAST ISOPLEX® VTEC

DNA/LYO3

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Mast Group Limited
Manufacturer SRN: GB-MF-000025209
UDI-DI: 15056152705326
Basic UDI-DI: 50561527LYO3NL
Reference: DNA/LYO3
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Mast Diagnostica GmbH
Last updated: 02.07.2026 01:54

Manufacturer products Authorised representative products Authorised representative actors View details

NeXgen 16HP

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zinexts Life Science Corp.
Manufacturer SRN: TW-MF-000026758
UDI-DI: 04719889680154
Basic UDI-DI: 471988968AA131F6
Reference: 131A1
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 00:31

Manufacturer products Authorised representative products Authorised representative actors View details

Chroma ATE

GenXplore q4800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CHROMA ATE INC.
Manufacturer SRN: TW-MF-000019529
UDI-DI: 04719889100102
Basic UDI-DI: 471988910GX2W
Reference: GenXplore q4800
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

04719880129751

SLA-E13200

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880129751
Basic UDI-DI: 471988012SLAE1320044
Reference: SLA-E13200
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880129485

Maelstrom 9600

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880129485
Basic UDI-DI: 471988012M96007R
Reference: Maelstrom 9600 (110V)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880129454

Maelstrom 9610

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880129454
Basic UDI-DI: 471988012M96107U
Reference: Maelstrom 9610 (220V)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880129171

Maelstrom 4810

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880129171
Basic UDI-DI: 471988012M481073
Reference: Maelstrom 4810 (110V)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880128884

Maelstrom 2410

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880128884
Basic UDI-DI: 471988012M24105Z
Reference: Maelstrom 2410 (220V)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880128822

Maelstrom 9610 LH

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880128822
Basic UDI-DI: 471988012M96LHBQ
Reference: Maelstrom 9610 LH
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Sweden
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880128600

Maelstrom 8 Autostage

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880128600
Basic UDI-DI: 471988012S04LG
Reference: Maelstrom Switch 8
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 808 Nucleic Acid Extraction System

IVD Class ANot specifiedOn the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702078
Basic UDI-DI: 695629970003P3
Reference: 501102
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 960 Nucleic Acid Extraction System

IVD Class ANot specifiedOn the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702085
Basic UDI-DI: 695629970003P3
Reference: 501103
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 824s Nucleic Acid Extraction System

IVD Class ANot specifiedOn the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702092
Basic UDI-DI: 695629970003P3
Reference: 501101
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity 2.0s System

IVD Class ANot specifiedOn the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703402
Basic UDI-DI: 695629970002NZ
Reference: 505102
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity 2.1 System

IVD Class ANot specifiedOn the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703679
Basic UDI-DI: 695629970002NZ
Reference: 505103
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

04262367270007

LabDisk-Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Dermagnostix GmbH
Manufacturer SRN: DE-MF-000025137
UDI-DI: 04262367270007
Basic UDI-DI: 426236727TD-AZ001GB
Reference: ESDR12-MB-1000
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:27

Manufacturer products View details

PoET Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370162
Basic UDI-DI: 42623533727MF
Reference: P9A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 23:26

Manufacturer products View details

careHPV Test Luminometer

IVD Class AIVDR 2017/746No longer on 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: 01.07.2026 19:23

Manufacturer products View details

QIAcuityDx Four

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228048770
Basic UDI-DI: 4053228IQCY000000000001U5
Reference: 911060
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:23

Manufacturer products View details