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

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Elisa Microplate Reader

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06978527670119
Basic UDI-DI: 6936895BS0052A
Reference: BK-EL10DA
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

HM-JACKarcⅡ

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295657873
Basic UDI-DI: 4987295BU002ZT
Reference: 65787
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

GBC Chemiluminescence Analyzer (Non-Sterile)

GBC CLi120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: General Biologicals Corporation
Manufacturer SRN: TW-MF-000024694
UDI-DI: 04712803533789
Basic UDI-DI: 4712803534MGCLI120JP
Reference: 4MGCLI120
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

CubePlus

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

Manufacturer: opTricon GmbH
Manufacturer SRN: DE-MF-000024656
UDI-DI: 04252020400179
Basic UDI-DI: 42520204CPLUSAP
Reference: CUBE-840-02
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Finland
Authorised representative: -
Last updated: 16.07.2026 09:14

Manufacturer products View details

SPINCHIP® SOFTWARE

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026646530
Basic UDI-DI: 357302BUDI002311TC
Reference: 425376
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 07:51

Manufacturer products View details

SpinChip SampleTransfer

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026646127
Basic UDI-DI: 357302BUDI002312TE
Reference: 543799
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 07:51

Manufacturer products View details

FIAPresto FIAVet

FIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bifour Biotech Inc.
Manufacturer SRN: US-MF-000034957
UDI-DI: 00860010246207
Basic UDI-DI: 08600102462BBIITRI001AN
Reference: FIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

BeVigilant™ Reader

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

Manufacturer: Vigilant Biosciences, Inc.
Manufacturer SRN: US-MF-000013534
UDI-DI: 00860000930987
Basic UDI-DI: 086000093099000011UM
Reference: 9000011
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Vigilant Biosciences GmbH
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

BeVigilant™ Reader

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

Manufacturer: Vigilant Biosciences, Inc.
Manufacturer SRN: US-MF-000013534
UDI-DI: 00860000930963
Basic UDI-DI: 086000093099000002UL
Reference: 9000002
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Vigilant Biosciences GmbH
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Buffer

NOVEOS® Immunoassay System Accessories

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hycor Biomedical LLC
Manufacturer SRN: US-MF-000031449
UDI-DI: 00816879023046
Basic UDI-DI: 081687902NOVACCKX
Reference: 63165
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

NOVEOS® Immunoassay System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hycor Biomedical LLC
Manufacturer SRN: US-MF-000031449
UDI-DI: 00816879022995
Basic UDI-DI: 081687902NOVINST37
Reference: 63000
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

00816870024448

IN006-3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870024448
Basic UDI-DI: 081687002IN006-3UR
Reference: IN006-3
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

00816870020082

IN006-2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020082
Basic UDI-DI: 081687002IN006-2UP
Reference: IN006-2
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

00816870020075

IN006

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020075
Basic UDI-DI: 081687002IN006ZU
Reference: IN006
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

00816870020068

IN013

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020068
Basic UDI-DI: 081687002IN013ZR
Reference: IN013
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

00816870020051

IN009

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020051
Basic UDI-DI: 081687002IN00925
Reference: IN009
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

00816870020013

IN008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020013
Basic UDI-DI: 081687002IN00823
Reference: IN008
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

00816870020006

IN010

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020006
Basic UDI-DI: 081687002IN010ZK
Reference: IN010
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:22

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: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510341
Basic UDI-DI: 0810164510010N4
Reference: EQA01-CL
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Cup Test Reader

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510327
Basic UDI-DI: 0810164510009NK
Reference: EQB01-RD
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details