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CONFIDANTE

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217919
Basic UDI-DI: 50552732ACONSTI017LZ
Reference: EV3879
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

Home Blood Sample Collection Kit

IVD Class AIVDR 2017/746On the marketNo EU repKitSingle use

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217254
Basic UDI-DI: 50552732AHBLSCK042AD
Reference: EV4460
EMDN: W0501010201
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

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

05051716000032

LTK.615

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Oxford Immunotec Ltd
Manufacturer SRN: GB-MF-000004429
UDI-DI: 05051716000032
Basic UDI-DI: 5051716LTKCA
Reference: LTK.615
EMDN: W050301020101
EMDN description: SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES
First on market country: Ireland
Authorised representative: Wallac Oy
Last updated: 31.07.2026 08:06

Manufacturer products Authorised representative products Authorised representative actors View details

TENCELL™ Cuvettes

IK702

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020909
Basic UDI-DI: 5051700IK702GP
Reference: IK702
EMDN: W0503010203
EMDN description: SAMPLES ANALYSES, PLASTIC CUVETTES
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:06

Manufacturer products Authorised representative products Authorised representative actors View details

EXENT® Disposable MALDI Plate Pack

IK819

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020688
Basic UDI-DI: 5051700IK819HD
Reference: IK819
EMDN: W05039080
EMDN description: DEVICES FOR SAMPLES ANALYSES - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:06

Manufacturer products Authorised representative products Authorised representative actors 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

Laser Embedding Cassettes - White

Embedding and Biopsy Cassettes

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Shandon Diagnostics Limited
Manufacturer SRN: GB-MF-000008187
UDI-DI: 05051663625357
Basic UDI-DI: 5051663SDL026KJ
Reference: 110-01-10LM
EMDN: W05020106
EMDN description: BIOPSY CARTRIDGES
First on market country: Netherlands
Authorised representative: Epredia Netherlands B.V.
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

05018632288999

SPECIMEN CONTAINERS

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Paul Murray plc
Manufacturer SRN: GB-MF-000009853
UDI-DI: 05018632288999
Basic UDI-DI: 5018632RECEPTACLES006M
Reference: SA8385
EMDN: W05010203
EMDN description: URINE COLLECTION, CONTAINERS
First on market country: Northern Ireland
Authorised representative: Murrays Health and Beauty Europe Limited
Last updated: 31.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

geneLEAD VIII Consumable Set

geneLEAD Consumable Set