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Last updated

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Active filter:EMDN:W0205

1000+ device results listed.

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HighPrep PCR - DX (500 mL)

Device for post-PCR and post-enzymatic reaction clean-up

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent
Manufacturer
MagBio Genomics, Inc.
Manufacturer SRN
US-MF-000038221
UDI-DI
00850045030155
Basic UDI-DI
0850045030AC-60500EA6
Reference
AC-60500E
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Germany
Authorised representative
CEpartner4U
Last updated
16.07.2026 06:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HighPrep PCR - DX (50 mL)

Device for post-PCR and post-enzymatic reaction clean-up

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent
Manufacturer
MagBio Genomics, Inc.
Manufacturer SRN
US-MF-000038221
UDI-DI
00850045030131
Basic UDI-DI
0850045030AC-60050E9U
Reference
AC-60050E
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Germany
Authorised representative
CEpartner4U
Last updated
16.07.2026 06:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HighPrep PCR - DX (5 mL)

Device for post-PCR and post-enzymatic reaction clean-up

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent
Manufacturer
MagBio Genomics, Inc.
Manufacturer SRN
US-MF-000038221
UDI-DI
00850045030124
Basic UDI-DI
0850045030AC-60005E9J
Reference
AC-60005E
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Germany
Authorised representative
CEpartner4U
Last updated
16.07.2026 06:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HighPrep PCR - DX (100 mL)

Device for post-PCR and post-enzymatic reaction clean-up

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent
Manufacturer
MagBio Genomics, Inc.
Manufacturer SRN
US-MF-000038221
UDI-DI
00850045030056
Basic UDI-DI
0850045030AC-60100E9A
Reference
AC-60100E
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Germany
Authorised representative
CEpartner4U
Last updated
16.07.2026 06:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Fluxergy Analyzer

Mk12.1

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing
Manufacturer
Fluxergy Inc.
Manufacturer SRN
US-MF-000010833
UDI-DI
00850027856124
Basic UDI-DI
0850027856MkD6W
Reference
5506-CE
EMDN
W02050199
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country
Greece
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
16.07.2026 06:21
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SureTyper™

STTPGRX

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing
Manufacturer
One Lambda, Inc.
Manufacturer SRN
US-MF-000024901
UDI-DI
00814695024933
Basic UDI-DI
081469502STPK8
Reference
STTPGRX
EMDN
W02050192
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country
Austria
Authorised representative
MDSS GmbH
Last updated
16.07.2026 04:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
TypeStream™ Visual Software version 3.2

TSVPRG

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing
Manufacturer
One Lambda, Inc.
Manufacturer SRN
US-MF-000024901
UDI-DI
00814695024445
Basic UDI-DI
081469502TSVKN
Reference
TSVPGR
EMDN
W02050292
EMDN description
MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country
Austria
Authorised representative
MDSS GmbH
Last updated
16.07.2026 04:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
GeneXpert®

GeneXpert® Infinity Systems

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing
Manufacturer
Cepheid
Manufacturer SRN
US-MF-000010979
UDI-DI
07332940007713
Basic UDI-DI
081164701-INFINITY-ZH
Reference
GX-INFINITY 48S
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Netherlands
Authorised representative
Cepheid AB
Last updated
16.07.2026 04:13
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
GeneXpert

GeneXpert® Dx Systems

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing
Manufacturer
Cepheid
Manufacturer SRN
US-MF-000010979
UDI-DI
07332940007683
Basic UDI-DI
081164701-GX-X5
Reference
GeneXpert II (GX-II)
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Netherlands
Authorised representative
Cepheid AB
Last updated
16.07.2026 04:13
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Xpert®

Xpert® Check

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use
Manufacturer
Cepheid
Manufacturer SRN
US-MF-000010979
UDI-DI
07332940001865
Basic UDI-DI
081164701-XPERTCHECK-3B
Reference
XPERTCHECK-CE-5
EMDN
W02050199
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country
Netherlands
Authorised representative
Cepheid AB
Last updated
16.07.2026 04:13
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
07350148190006

Qlucore Diagnostics Platform

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissues
Manufacturer
Qlucore AB(publ)
Manufacturer SRN
SE-MF-000030781
UDI-DI
07350148190006
Basic UDI-DI
07350148191KA
Reference
QD Platform,
EMDN
W02050192
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country
Denmark
Authorised representative
-
Last updated
16.07.2026 03:02
Manufacturer productsView details
FOX

BD FOX™ PCR Extraction Tubes

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
30382904419920
Basic UDI-DI
038290ZMTAUZEXRG
Reference
441992
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Belgium
Authorised representative
Becton Dickinson Ireland Limited
Last updated
15.07.2026 23:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
FOX

BD FOX™ Extraction Tubes

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
30382904411290
Basic UDI-DI
038290OJLDQOTODD
Reference
441129
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Belgium
Authorised representative
Becton Dickinson Ireland Limited
Last updated
15.07.2026 23:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Not Applicable

BD PCR Cartridge

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
30382904375196
Basic UDI-DI
038290YMCUPXTNQ8
Reference
437519
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Belgium
Authorised representative
Becton Dickinson Ireland Limited
Last updated
15.07.2026 23:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
COR

BD COR™ GX INSTRUMENT

IVD Class AIVDR 2017/746On the marketAnimal tissuesInstrumentProfessional testing
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
00382904439903
Basic UDI-DI
038290TFCJEOYLAA
Reference
443990
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Belgium
Authorised representative
Becton Dickinson Ireland Limited
Last updated
15.07.2026 23:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MAX

BD MAX™ System

IVD Class AIVDR 2017/746On the marketAnimal tissuesInstrumentProfessional testing
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
00382904419165
Basic UDI-DI
038290UZTXHTZA26
Reference
441916
EMDN
W02050116
EMDN description
NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country
Belgium
Authorised representative
Becton Dickinson Ireland Limited
Last updated
15.07.2026 23:43
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
VIPER

BD Specimen Tubes and Caps for use on the BD Viper™ System

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
30382904413607
Basic UDI-DI
038290IEHRMMUH8T
Reference
441360
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Belgium
Authorised representative
Becton Dickinson Ireland Limited
Last updated
15.07.2026 23:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Not Applicable

BD Pre-warm Heater

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
00382904431594
Basic UDI-DI
038290MLZISLOML2
Reference
443159
EMDN
W02050180
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country
Belgium
Authorised representative
Becton Dickinson Ireland Limited
Last updated
15.07.2026 23:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
VIPER

BD Viper™ LT System PCR Accessory Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
00382904429676
Basic UDI-DI
038290KNHKHNPYC2
Reference
442967
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Belgium
Authorised representative
Becton Dickinson Ireland Limited
Last updated
15.07.2026 23:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
VIPER

BD Viper™ LT System PCR Tube / Tray Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
00382904429577
Basic UDI-DI
038290GHEXZRWPED
Reference
442957
EMDN
W02050185
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country
Belgium
Authorised representative
Becton Dickinson Ireland Limited
Last updated
15.07.2026 23:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details