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

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VIDAS® Quality Control

VIDAS® Quality Control

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026121631
Basic UDI-DI: 357302BUDI000250T3
Reference: 30706
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:50

Manufacturer products View details

DS2 / DSX REAGENT TIPS

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180034
Basic UDI-DI: 506045618DS2DE
Reference: 65920
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

DS2 / DSX SAMPLE TIP

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180041
Basic UDI-DI: 506045618DS2DE
Reference: 65910
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

AGILITY SAMPLE TIPS

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180072
Basic UDI-DI: 506045618AGILITYBB
Reference: 67910
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

AGILITY REAGENT TIPS

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180089
Basic UDI-DI: 506045618AGILITYBB
Reference: 6792-
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

DSX Automated ELISA System with 2 incubators

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180157
Basic UDI-DI: 506045618DSXFQ
Reference: 65200
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

DSX Automated ELISA with 2 incubators and sample ID

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180218
Basic UDI-DI: 506045618DSXFQ
Reference: 65300
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

DSX Automated ELISA System - Ambient

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180287
Basic UDI-DI: 506045618DSXFQ
Reference: 65100
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

DSX Automated ELISA with 4 incubators and sample ID

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180300
Basic UDI-DI: 506045618DSXFQ
Reference: 65500
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

DS2 without Barcode Scanner

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180317
Basic UDI-DI: 506045618DS2DE
Reference: 62000
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

AGILITY SOFTWARE

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180539
Basic UDI-DI: 506045618AGILITYBB
Reference: 67800
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Revelation DSX Software

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180546
Basic UDI-DI: 506045618DSXFQ
Reference: 65078
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

DEEP WELL STRIPS

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180614
Basic UDI-DI: 506045618DS2DE
Reference: 62910
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

DS Matrix Software

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180690
Basic UDI-DI: 506045618DS2DE
Reference: 62800
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the market

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456182434
Basic UDI-DI: 506045618AGILITYBB
Reference: 67000AI
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: 19.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

M2

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600329
Basic UDI-DI: 695441761107R832
Reference: NA
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 17.07.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

IVDR_27_MAR EB_A_INST_BNII

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414655598
Basic UDI-DI: 0405686900856W6
Reference: 11539176
EMDN: W0201020204
EMDN description: NEPHELOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 17.07.2026 23:43

Manufacturer products View details

Fluorescence Immunoassay Analyzer

-

IVD Class ANot specifiedOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109831280
Basic UDI-DI: 5060599400002PNT
Reference: RL-FA-3B
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

-

IVD Class ANot specifiedOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109831594
Basic UDI-DI: 5060599400002PNT
Reference: RL-FA-2B
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

-

IVD Class ANot specifiedOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109831600
Basic UDI-DI: 5060599400002PNT
Reference: RL-FA-3C
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details