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REFERENCE SOLUTION (REF SOLN)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273214338
Basic UDI-DI: 50552732AREFSOL014LC
Reference: RX4045
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

Optilite® Special Wash 1

IK707

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700017831
Basic UDI-DI: 5051700IK707GZ
Reference: IK707
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:05

Manufacturer products Authorised representative products Authorised representative actors View details

Optilite® Diluent 3

IK711

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700017435
Basic UDI-DI: 5051700IK711GQ
Reference: IK711
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:05

Manufacturer products Authorised representative products Authorised representative actors View details

Optilite® Diluent 2

IK710

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700017107
Basic UDI-DI: 5051700IK710GN
Reference: IK710
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

Optilite Diluent 1

IK709

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700017091
Basic UDI-DI: 5051700IK709H5
Reference: IK709
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

SPAPLUS® SAMPLE DILUENT 2 PACK

SN114.S

IVD Class AIVDR 2017/746No longer on the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700015554
Basic UDI-DI: 5051700SN114.S9F
Reference: SN114.S
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

SPAPLUS® SAMPLE DILUENT PACK

SN080.S

IVD Class AIVDR 2017/746No longer on the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700011051
Basic UDI-DI: 5051700SN080.S9Z
Reference: SN080.S
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

Micro tube 1.5mL(200pcs)

MagDEA Dx MV

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869644605
Basic UDI-DI: 4987869ConsumableT3
Reference: F4460
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

geneLEAD Waste Box

Waste Box

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869621255
Basic UDI-DI: 4987869WasteBoxHZ
Reference: F2125
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Solution A

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274125874
Basic UDI-DI: 4987274W0580WSA00G9
Reference: 912587
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
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

04980679161515

Wash solution

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: JOKOH CO.,LTD.
Manufacturer SRN: JP-MF-000025161
UDI-DI: 04980679161515
Basic UDI-DI: 498067916151L8
Reference: J16151
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Lithuania
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

MagSi-DX Blood

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: magtivio B.V.
Manufacturer SRN: NL-MF-000023114
UDI-DI: 04260350320005
Basic UDI-DI: 426035032DX0002PJ
Reference: MDDX00020960
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 01:54

Manufacturer products View details

04250380309866

Anti-DIG/DNP-Mix

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

Manufacturer: ZytoVision GmbH
Manufacturer SRN: DE-MF-000024390
UDI-DI: 04250380309866
Basic UDI-DI: 4250380S598Y
Reference: AB-0014-16
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:35

Manufacturer products View details

04250380309835

HRP/AP-Polymer-Mix

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: ZytoVision GmbH
Manufacturer SRN: DE-MF-000024390
UDI-DI: 04250380309835
Basic UDI-DI: 4250380S548N
Reference: AB-0013-1
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:35

Manufacturer products View details

04250380309811

Nuclear Blue Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: ZytoVision GmbH
Manufacturer SRN: DE-MF-000024390
UDI-DI: 04250380309811
Basic UDI-DI: 4250380S418D
Reference: CS-0002-4
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:35

Manufacturer products View details

04250380309804

Heat Pretreatment Solution Citric

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: ZytoVision GmbH
Manufacturer SRN: DE-MF-000024390
UDI-DI: 04250380309804
Basic UDI-DI: 4250380S238B
Reference: PT-0001-500
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:35

Manufacturer products View details

04250380308715

HRP-Green Solution B

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: ZytoVision GmbH
Manufacturer SRN: DE-MF-000024390
UDI-DI: 04250380308715
Basic UDI-DI: 4250380S588W
Reference: SB-0007b-4
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:35

Manufacturer products View details

04250380308685

HRP-Green Solution A

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: ZytoVision GmbH
Manufacturer SRN: DE-MF-000024390
UDI-DI: 04250380308685
Basic UDI-DI: 4250380S578U
Reference: SB-0007a-0.8
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:35

Manufacturer products View details

04250380308661

AP-Red Solution B

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: ZytoVision GmbH
Manufacturer SRN: DE-MF-000024390
UDI-DI: 04250380308661
Basic UDI-DI: 4250380S568S
Reference: SB-0006b-4
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:35

Manufacturer products View details

04250380308630

AP-Red Solution A

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: ZytoVision GmbH
Manufacturer SRN: DE-MF-000024390
UDI-DI: 04250380308630
Basic UDI-DI: 4250380S558Q
Reference: SB-0006a-0.4
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:35

Manufacturer products View details