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EUDAMED Device Search

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

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Portable Lateral Flow (LF) Reader

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

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

Urine Analyzer

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109830221
Basic UDI-DI: 5060599400002QNV
Reference: RL-UA-5A
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
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

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

Cholesterol Meter

Cholesterol Meter

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061027264412
Basic UDI-DI: 5060599401942YP
Reference: RL-CHOM-1A
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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

Hb Hemoglobin Test Meter

Hb Hemoglobin Test Meter

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05060599403311
Basic UDI-DI: 5060599400002SNZ
Reference: RL-HBM-1A
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
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

Cup Reader

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05060599403274
Basic UDI-DI: 5060599401040X6
Reference: RL-CD-1A
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

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Automatic Chemiluminescence Immunoassay Analyzer

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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Benchbot® 4800

4800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830750
Basic UDI-DI: 506053683BBOT01ZU
Reference: BBOT4800
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

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

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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

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

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

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

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