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153 device results listed.

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Washing Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576205777
Basic UDI-DI: 697457620FGWS01QT
Reference: GFQXY02Q
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 07.08.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

HM-JACK Sample Cup

HM-JACKarcⅡ

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295531517
Basic UDI-DI: 4987295BU002ZT
Reference: 53151
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

i-Track 10 Trigger Set

IS-CT100

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immunodiagnostic Systems SA
Manufacturer SRN: BE-MF-000015341
UDI-DI: 05425030420027
Basic UDI-DI: 5425030421024R9
Reference: TD IS-CT100
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

i-Track 10 System Liquid

IS-CS100

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Immunodiagnostic Systems SA
Manufacturer SRN: BE-MF-000015341
UDI-DI: 05425030420010
Basic UDI-DI: 5425030421017RC
Reference: TD IS-CS100
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

i-Track 10 Wash Solution

IS-CW100

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Immunodiagnostic Systems SA
Manufacturer SRN: BE-MF-000015341
UDI-DI: 05425030420003
Basic UDI-DI: 5425030421031R6
Reference: TD IS-CW100
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

AIA-PACK WASH CONCENTRATE

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Tosoh Europe N.V.
Manufacturer SRN: BE-MF-000000210
UDI-DI: 04562185380033
Basic UDI-DI: 5430000495000020955MW
Reference: 0020955
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:57

Manufacturer products View details

AIA-PACK DILUENT CONCENTRATE

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Tosoh Europe N.V.
Manufacturer SRN: BE-MF-000000210
UDI-DI: 04562185380026
Basic UDI-DI: 5430000495000020956MY
Reference: 0020956
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:57

Manufacturer products View details

IDS Immunocleaner

IS-IM100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693906
Basic UDI-DI: 5060169693906Y9
Reference: IS-IM100
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS Diluent C

IS-10DC

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693418
Basic UDI-DI: 5060169693418XP
Reference: IS-10DC
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS D-Sorb Solution

IS-DS200

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169692305
Basic UDI-DI: 5060169692305X2
Reference: IS-DS200
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS Diluent B

IS-10DB

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169691100
Basic UDI-DI: 5060169691100W7
Reference: IS-10DB
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS Diluent A

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169691094
Basic UDI-DI: 5060169691094X5
Reference: IS-10DA
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

WASH BUFFER CONCENTRATE (BUF WASH (conc.))

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273202663
Basic UDI-DI: 50552732ABUFWAS021GL
Reference: EV3581
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

DISPLACEMENT FLUID CONCENTRATE (DISP FL (conc.))

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273202656
Basic UDI-DI: 50552732ADISFLU049FT
Reference: EV3580
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

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

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