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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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23.09.2026 08:13

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740 device results listed.

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HE0030N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042047
Basic UDI-DI: 08453570HE0030NYH
Reference: [HE0030N] Helix Elite™ Molecular Standards Inactivated Influenza B Virus Strain Hong Kong/5/72
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0029N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042030
Basic UDI-DI: 08453570HE0029NZ7
Reference: [HE0029N] Helix Elite™ Molecular Standards Inactivated Influenza A (H1N1) Virus
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0028N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042023
Basic UDI-DI: 08453570HE0028NZ4
Reference: [HE0028N] Helix Elite™ Molecular Standards Inactivated Respiratory Syncytial Virus A Strain Long
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

HE0027N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042016
Basic UDI-DI: 08453570HE0027NYZ
Reference: [HE0027N] Helix Elite™ Molecular Standards Inactivated Rotavirus Strain Simian SA-11
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

HE0026N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042009
Basic UDI-DI: 08453570HE0026NYW
Reference: [HE0026N] Helix Elite™ Molecular Standards Inactivated Adenovirus 2 Strain Adenoid 6
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol Chagas-2, 1x pos, 1mL

SR16035

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075957101
Basic UDI-DI: 0816784020107XU
Reference: SR16035
EMDN: W0105080804
EMDN description: OTHER VIROLOGY 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 Chagas-1, 1x pos, 1mL

SR16025

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075957088
Basic UDI-DI: 0816784020106XS
Reference: SR16025
EMDN: W0105080804
EMDN description: OTHER VIROLOGY 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 Mumps M, 1x pos, 1mL

SR15065

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075957033
Basic UDI-DI: 0816784020091Y6
Reference: SR15065
EMDN: W0105080804
EMDN description: OTHER VIROLOGY 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 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 Paediatric G negative, 2x neg, 2,5mL

SR15025

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956388
Basic UDI-DI: 0816784020098YL
Reference: SR15006
EMDN: W0105080804
EMDN description: OTHER VIROLOGY 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