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pureNA® Cell-Free DNA Isolation Kit

pureNA® Cell-Free DNA Isolation Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830576
Basic UDI-DI: 506053683CFDNA1ZS
Reference: CFDNA-50
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Czechia
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details

ZINC DEPROTEINIZING SOLUTION (Zn)

ZINC DEPROTEINIZING SOLUTION (Zn)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273207002
Basic UDI-DI: 50552732AZNDPSN050X4
Reference: ZN2607
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

RANSOD DILUENT (RANSOD DIL)

RANSOD DILUENT (RANSOD DIL)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273206142
Basic UDI-DI: 50552732ARANDIL045EE
Reference: SD124
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

NORMAL SALINE (NS)

SALINE DILUENT

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273206111
Basic UDI-DI: 50552732ASALDIL007DT
Reference: SA3854
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

I.S.E. URINE DILUENT (ISE DIL URN)

I.S.E. URINE DILUENT (ISE DIL URN)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273205961
Basic UDI-DI: 50552732AISEDIL005DG
Reference: RX3950
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

SERUM DILUENT (DIL SM)

SERUM DILUENT (DIL SM)

IVD Class AIVDR 2017/746On the marketNo EU repKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204667
Basic UDI-DI: 50552732ASERDIL048KT
Reference: MS5007
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

UF-CELLSHEATH

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562433926
Basic UDI-DI: 4987562UF-CELLSHEATHLK
Reference: BY-074-501
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolysis Solution

Hemolysis Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486043768
Basic UDI-DI: 4987486BC0109274HC
Reference: 109274
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

HEMOLYSIS WASHING SOLUTION Lite H

HEMOLYSIS WASHING SOLUTION Lite H

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033776
Basic UDI-DI: 4987486BC0107378HB
Reference: 107378
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

DILUENT 90

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033745
Basic UDI-DI: 4987486BC0107375H5
Reference: 107375
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

HEMOLYSIS WASHING SOLUTION 90H

HEMOLYSIS WASHING SOLUTION 90H

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033738
Basic UDI-DI: 4987486BC0107374H3
Reference: 107374
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

CONTROL DILUTION SET 80

CONTROL DILUTION SET 80

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033554
Basic UDI-DI: 4987486BC0107350GM
Reference: 107350
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

HEMOLYSIS WASHING SOLUTION 80H

HEMOLYSIS WASHING SOLUTION 80H

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486033547
Basic UDI-DI: 4987486BC0107349H4
Reference: 107349
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

FIT AA01 Specimen Diluent

FIT AA01 Specimen Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274139376
Basic UDI-DI: 4987274W01019001SPD026H
Reference: 913937
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

FIT NS-Prime Specimen Diluent

FIT NS-Prime Specimen Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274108747
Basic UDI-DI: 4987274W01019001SPD016F
Reference: 910874
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

CatFlux Solutions

CatFlux Solutions for the CatSper Test, CatFlux Control and Test Solution

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Truion GmbH
Manufacturer SRN: DE-MF-000034807
UDI-DI: 04270003742504
Basic UDI-DI: 42700037425CATfluxGN
Reference: P1001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:47

Manufacturer products View details

- deltaPREP Blood DNA Kit – PP Mini (MDX) Strip 96 rxn

deltaPREP Blood DNA Kit – PP Mini (MDX)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375225068
Basic UDI-DI: 4262375220058R
Reference: 31-DP-7000096
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details

PurePrep Path DX Kit (96 rxn)

deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375224047
Basic UDI-DI: 4262375220048P
Reference: MGV000483
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (96 rxn) Sprips

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16rxn) Stripes

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375223033
Basic UDI-DI: 4262375220038M
Reference: 31-DP-5010096
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details

deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (96 rxn) stripes

deltaPREP Blood DNA Mini Kit – IPC16 (MDX)

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: IST Innuscreen GmbH
Manufacturer SRN: DE-MF-000024606
UDI-DI: 04262375222036
Basic UDI-DI: 4262375220028K
Reference: 31-DP-5000096
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:29

Manufacturer products View details