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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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732 device results listed.

Page 13 / 37

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

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

Optitrol NAT Triplex, 10x 1,2 mL

NT01041

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956319
Basic UDI-DI: 0816784020092Y8
Reference: NT01042
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 NAT Parvo B19, 10x 1,2 mL

NT05021

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956289
Basic UDI-DI: 0816784020103XL
Reference: NT05022
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 NAT NEG, 5x 1,2 mL

NT01051

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956265
Basic UDI-DI: 0816784020093YA
Reference: NT01051
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 NAT HIV-2, 5x 1,2 mL

NT01035

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956203
Basic UDI-DI: 0816784020102XJ
Reference: NT01035
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 NAT HIV Screening, 5x 1,2 mL

NT01031

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956166
Basic UDI-DI: 0816784020095YE
Reference: NT01031
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 NAT HIV Viral Load, 5x 1.2 mL

NT01033

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956180
Basic UDI-DI: 0816784020113XP
Reference: NT01033
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 NAT HCV Viral Load, 5x 1.2 mL

NT01023

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956128
Basic UDI-DI: 0816784020112XM
Reference: NT01023
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 NAT HCV Screening, 5x 1,2 mL

NT01021

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956104
Basic UDI-DI: 0816784020096YG
Reference: NT01021
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 NAT HBV Viral Load, 5x 1.2 mL

NT01013

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956081
Basic UDI-DI: 0816784020111XK
Reference: NT01013
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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 NAT HBV Screening, 5x 1,2 mL

NT01011

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956067
Basic UDI-DI: 0816784020094YC
Reference: NT01011
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
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

Multichem ID Multi-Marker Negative Control 2 x 4mL

Multichem ID Multi-Marker Negative Control 2 x 4mL

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substances

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090917
Basic UDI-DI: 0816784020080XZ
Reference: 2010-0260
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

Multichem ID HAV IgM Positive Control

Multichem ID HAV IgM Positive Control

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090900
Basic UDI-DI: 0816784020081Y3
Reference: 2015-0337
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN Babesia Molecular Controls Kit

2020-0155

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090047
Basic UDI-DI: 0816784020062XX
Reference: 2020-0155
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details