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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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01.08.2026 01:12

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137 device results listed.

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8189

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357041196
Basic UDI-DI: 084535708189BT
Reference: [8189] QC Sets and Panels: Helix Elite™ Trichomonas vaginalis (TV) Control Panel (Inactivated Swab)
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol HEPR-2, 1x pos, 1mL

SR12057

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956999
Basic UDI-DI: 0816784020090Y4
Reference: SR12055
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol HEPA-2, 1x pos, 1mL

SR12035

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956951
Basic UDI-DI: 0816784020100XE
Reference: SR12035
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol HEPA-1, 1x pos, 1mL

SR12025

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956937
Basic UDI-DI: 0816784020099YN
Reference: SR12025
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol HIV 2, 4x pos, 2.5mL

SR11113

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956906
Basic UDI-DI: 0816784020110XH
Reference: SR11113
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol HIV p24, 4x pos, 5mL

SR11101

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956869
Basic UDI-DI: 0816784020105XQ
Reference: SR11101
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

SR11019

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956852
Basic UDI-DI: 0816784020089YK
Reference: SR11019
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

SR11013

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956845
Basic UDI-DI: 0816784020088YH
Reference: SR11013
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

SR11011

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956838
Basic UDI-DI: 0816784020087YF
Reference: SR11011
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Yellow 4x5 mL

SR11021

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956692
Basic UDI-DI: 0816784020108XW
Reference: SR11021
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol SeroNeg, 4x neg, 1mL

SR11000

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956524
Basic UDI-DI: 0816784020109XY
Reference: SR11000
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Red, 2x pos, 5mL

SR11051

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956494
Basic UDI-DI: 0816784020101XG
Reference: SR11053
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Orange, 2x pos, 5mL

SR11061

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956333
Basic UDI-DI: 0816784020097YJ
Reference: SR11063
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus and Adenovirus Antigen Control Kit

GCROA/ADE-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCROA/ADE-PN2QK
Basic UDI-DI: B-GCROA/ADE-PN2QK
Reference: GCROA/ADE-PN2
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus and Adenovirus Antigen Control Kit

GCROA/ADE-PN2

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCROA/ADE-PN2HGHB
Basic UDI-DI: B-GCROA/ADE-PN2HGHB
Reference: GCROA/ADE-PN2
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B/RSV/Adeno Ag Control Kit

GCFCRA-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRA-PN27N
Basic UDI-DI: B-GCFCRA-PN27N
Reference: GCFCRA-PN2
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Positive Control CSF

RIDA®Plex Positive Control CSF

IVD Annex II List BIVDDOn the marketProfessional testingReagent

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006838
Basic UDI-DI: B-09343044006838
Reference: 91081
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:46

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RIDA®Plex Positive Control Pneumonia

RIDA®Plex Positive Control Pneumonia

IVD Annex II List BIVDDOn the marketProfessional testing

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006821
Basic UDI-DI: B-09343044006821
Reference: 91071
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Positive Control Faecal Pathogens

RIDA®Plex Positive Control Faecal Pathogens

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006814
Basic UDI-DI: B-09343044006814
Reference: 91031
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:45

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RIDA®Plex Positive Control Respiratory Pathogens

91011

IVD Annex II List BIVDDOn the marketProfessional testing

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006807
Basic UDI-DI: B-09343044006807
Reference: 91011
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details