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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

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

QIAstat-Dx Rise

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228041849
Basic UDI-DI: 4053228IQSTAR0000000001VV
Reference: 9003163
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 01.07.2026 19:23

Manufacturer products View details

EZ2 Connect MDx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228040576
Basic UDI-DI: 4053228IEZ2000000000001QM
Reference: 9003230
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:23

Manufacturer products View details

QIAcube Connect MDx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228039129
Basic UDI-DI: 4053228IQCC000000000001XU
Reference: 9003070
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:23

Manufacturer products View details

QIAstat-Dx Analytical Module

QIAstat-Dx Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228033929
Basic UDI-DI: 4053228IQSTA00000000001VT
Reference: 9002814
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

Hybrid Capture System Rotary Shaker 1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 04053228028031
Basic UDI-DI: 4053228IHCSSHAKER0000013S
Reference: 6000-2240E
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Austria
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:23

Manufacturer products Authorised representative products Authorised representative actors View details

Rotor-Gene Q MDx 5Plex

Rotor-Gene Q MDx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228022077
Basic UDI-DI: 4053228IRGQ000000000001QQ
Reference: 9002020
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:22

Manufacturer products View details

Rapid Capture System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 04053228010821
Basic UDI-DI: 4053228IHPVRCS000000001K8
Reference: 6000-3101
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Austria
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

DML 3000

digene Microplate Luminometer 3000 (DML 3000)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 04053228010777
Basic UDI-DI: 4053228IHC2DML0000000017V
Reference: 5000-00031
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details