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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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954 device results listed.

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PATHODX HERPES TYPING CONTROL SLIDES

PATHODX HERPES TYPING CONTROL SLIDES

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080500010
Basic UDI-DI: 50560805PathoDXSlideHSV2N
Reference: R62251
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

SEROLOGY HBeAg POSITIVE CONTROL (HBeAg CONTROL +)

SEROLOGY HBeAg POSITIVE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217933
Basic UDI-DI: 50552732BHBPOCT140DS
Reference: SR10459
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

SEROLOGY HIV-1 P24Ag POSITIVE CONTROL (HIV-1 P24Ag CONTROL +)

SEROLOGY HIV-1 P24Ag POSITIVE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273217100
Basic UDI-DI: 50552732BAGPOCO125AR
Reference: SR10458
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL NEGATIVE)

SEROLOGY CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216493
Basic UDI-DI: 50552732BSECONT122LA
Reference: SR10351
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

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SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -)

SEROLOGY ToRCH CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216400
Basic UDI-DI: 50552732BSETECO123LF
Reference: SR10347
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)

SEROLOGY LYME DISEASE CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216387
Basic UDI-DI: 50552732BSELYDC124N4
Reference: SR10345
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

993-04201, 997-04101, 995-04401

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481163829
Basic UDI-DI: 498748114987481163802ZB
Reference: 995-04401
EMDN: W0105080806
EMDN description: MYCOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

Standard Gas

IVD Class BIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Otsuka Electronics Co., Ltd.
Manufacturer SRN: JP-MF-000001943
UDI-DI: 04987035485513
Basic UDI-DI: 498703502SG460644FU
Reference: UB-SP-012
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)

FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430225
Basic UDI-DI: 426242043GEN111SF
Reference: FR118
EMDN: W0105080908
EMDN description: STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:32

Manufacturer products View details

KWIK-STIK™ and LYFO DISK™

0262

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357004717
Basic UDI-DI: 0845357002629L
Reference: [0262U] KWIK-STIK™ S. marcescens ATCC 43862™
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

KWIK-STIK™ and LYFO DISK™

0156

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357001600
Basic UDI-DI: 0845357001569L
Reference: [0156L] LYFO DISK™ M. hominis ATCC 15488™
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

KWIK-STIK™ and LYFO DISK™

0151

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357001457
Basic UDI-DI: 0845357001519A
Reference: [0151L] LYFO DISK™ U. parvum ATCC 27813™
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

BACTERIAL ANTIGENS

No

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673252113
Basic UDI-DI: B-08431673252113
Reference: 1205211
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:07

Manufacturer products View details

BACTERIAL ANTIGENS

No

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673252014
Basic UDI-DI: B-08431673252014
Reference: 1205201
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:07

Manufacturer products View details

LIAISON® Control QuantiFERON®-TB Gold Plus II

LIAISON® Control QuantiFERON®-TB Gold Plus II

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104463
Basic UDI-DI: 805677131109142
Reference: 311091
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

LIAISON® MUREX Control Anti-HEV IgM

LIAISON® MUREX Control Anti-HEV IgM

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103923
Basic UDI-DI: 805677131128149
Reference: 311281
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

LIAISON® Control LymeDetect®

LIAISON® Control LymeDetect®

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103749
Basic UDI-DI: 80567713110313G
Reference: 311031
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

LIAISON® Control Rubella IgG II

LIAISON® Control Rubella IgG II

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771102957
Basic UDI-DI: 80567713172615D
Reference: 317261
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

LIAISON® Control Mumps IgG

LIAISON® Control Mumps IgG

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771101394
Basic UDI-DI: B-08056771101394
Reference: 318841
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:39

Manufacturer products View details

LIAISON® Control Mumps IgM

LIAISON® Control Mumps IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771101370
Basic UDI-DI: 805677131883169
Reference: 318831
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:39

Manufacturer products View details