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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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RoboBlot

RB01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bee Robotics
Manufacturer SRN: GB-MF-000023998
UDI-DI: 05060969430008
Basic UDI-DI: 506096943RB01AQ
Reference: RB01
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Lateral Flow (LF) Reader

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109830252
Basic UDI-DI: 5060599400002TP3
Reference: RT-ATR-001
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109830245
Basic UDI-DI: 5060599400002PNT
Reference: RL-FA-2A
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Lateral Flow Reader Plus

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109830061
Basic UDI-DI: 5060599400002UP5
Reference: RL-RD-3A
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05060599402017
Basic UDI-DI: 5060599401038XK
Reference: RL-CLIA-1A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

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AGILITY

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180058
Basic UDI-DI: 506045618AGILITYBB
Reference: 67000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

DSX Automated ELISA System with 4 incubators

DSX

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180010
Basic UDI-DI: 506045618DSXFQ
Reference: 65400
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

DS2 Automated ELISA System with Barcode scanner

DS2

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180003
Basic UDI-DI: 506045618DS2DE
Reference: 62010
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

IDS i20

IS-910400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169696693
Basic UDI-DI: 5060169696693Z4
Reference: IS-910400
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:33

Manufacturer products Authorised representative products Authorised representative actors View details

i-Tracker10

IS-810410

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169696594
Basic UDI-DI: 5060169699625Z8
Reference: TD 810400
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:33

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-i10

IS-810400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693968
Basic UDI-DI: 5060169693968YX
Reference: IS-810400
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
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 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

EVIDENCE+

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216691
Basic UDI-DI: 50552732AEVIDEN019DW
Reference: EV4400
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

evidence MULTISTAT

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273214970
Basic UDI-DI: 50552732AEVMULT038SS
Reference: EV4115
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

evidence INVESTIGATOR

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273209952
Basic UDI-DI: 50552732AEVINVE026MR
Reference: EV3602
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products 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