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SIGNAL REAGENTS – EV805 (REAG SGNL – EV805)

SIGNAL REAGENTS (REAG SGNL)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273202335
Basic UDI-DI: 50552732AREASGN020F8
Reference: EV3529
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

Optilite® Analyser

IE700

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020893
Basic UDI-DI: 5051700IE700F9
Reference: IE700
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
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® Analyser

IE800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020879
Basic UDI-DI: 5051700IE800FE
Reference: IE800
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
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® Wash Solution 1

IK822

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020695
Basic UDI-DI: 5051700IK822H2
Reference: IK822
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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® Mass Calibration Standard 1

MSS801.M

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020671
Basic UDI-DI: 5051700MSS801.MJH
Reference: MSS801.M
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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® HCCA MALDI Matrix Pack

IK820

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020664
Basic UDI-DI: 5051700IK820GW
Reference: IK820
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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

EXENT® Elution Buffer 1

IK877

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020657
Basic UDI-DI: 5051700IK877HT
Reference: IK877
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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

EXENT® Diluent 1

IK876

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700020640
Basic UDI-DI: 5051700IK876HR
Reference: IK876
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
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

HM-JACK Reaction Cell

HM-JACKarcⅡ

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295531500
Basic UDI-DI: 4987295BU002ZT
Reference: 53150
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

04987562445622

Line Washing Solution Supply Unit LU-10

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562445622
Basic UDI-DI: 4987562LU-103T
Reference: BR373361
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

04987562434060

Automated Immunoassay System HISCL-800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562434060
Basic UDI-DI: 4987562HISCL-800LK
Reference: AE999369
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

04987562429981

Automated Immunoassay System HISCL-5000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562429981
Basic UDI-DI: 4987562HISCL-5000X8
Reference: AF022051
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

04987562429424

HISCL Cuvette L

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562429424
Basic UDI-DI: 4987562HISCLCuvetteL4H
Reference: CP-815-570
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

04987562410989

HISCL DISPOSABLE TIP

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562410989
Basic UDI-DI: 4987562HISCLDISPOTIPHD
Reference: 064-5141-9
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

STROMATOLYSER-3WP

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562022090
Basic UDI-DI: 4987562STROMATOLYSER3WPE8
Reference: 854-0012-1
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

HM-CODIAM

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295660903
Basic UDI-DI: 4987295BU00422
Reference: 66090
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Liquid (Auto Detergent H)

HM-JACKarcⅡ

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295524045
Basic UDI-DI: 4987295BU002ZT
Reference: 52404
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

OC-SENSOR PLEDIA

OC Equipment Family

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026213194
Basic UDI-DI: 4987026TD-OCEQZ5
Reference: MV5H00
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

Agnitio BioIC Analyzer

BA-G2000 series/BA-G2012 series/BA400 series/ BA1200 series/BA2400 series

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AGNITIO SCIENCE &TECHNOLOGY,INC.
Manufacturer SRN: TW-MF-000040942
UDI-DI: 04719892999014
Basic UDI-DI: 471989299Analyzer8A
Reference: BA-G2000 series
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185396904
Basic UDI-DI: 45601892100040047M
Reference: 0023650
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors View details