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05070002421351

Dxcover Autosampler

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Dxcover Limited
Manufacturer SRN: UK-MF-000046906
UDI-DI: 05070002421351
Basic UDI-DI: 50700024213AutosamplerAQ
Reference: DXC-AS-001
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

05070002421313

Dxcover Sample Slides

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Dxcover Limited
Manufacturer SRN: UK-MF-000046906
UDI-DI: 05070002421313
Basic UDI-DI: 50700024213SampleSlidesNW
Reference: DXC-SS-001
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 09:19

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05070002421306

Dxcover Brain Cancer Diagnostic Software

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Dxcover Limited
Manufacturer SRN: UK-MF-000046906
UDI-DI: 05070002421306
Basic UDI-DI: 50700024213LiqBiopPltfm4Y
Reference: DXCBRAIN
EMDN: W0201010192
EMDN description: CHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

B20

BB20-NH

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bee Robotics
Manufacturer SRN: GB-MF-000023998
UDI-DI: 05060969430053
Basic UDI-DI: 506096943BB20NHYQ
Reference: BB20-NH
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Romania
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

B20

BB20-H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bee Robotics
Manufacturer SRN: GB-MF-000023998
UDI-DI: 05060969430046
Basic UDI-DI: 506096943BB20H2S
Reference: BB20-H
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Romania
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BeeBlot

BB10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bee Robotics
Manufacturer SRN: GB-MF-000023998
UDI-DI: 05060969430039
Basic UDI-DI: 506096943BB1079
Reference: BB10
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

BeeBlot

BB05

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bee Robotics
Manufacturer SRN: GB-MF-000023998
UDI-DI: 05060969430022
Basic UDI-DI: 506096943BB057G
Reference: BB05
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

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

Uric Acid Meter

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05061109830269
Basic UDI-DI: 5060599401966Z5
Reference: RL-AUAR-100
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

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

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

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

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

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

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

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

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