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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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07.07.2026 08:04

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675 device results listed.

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STREPTEX

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

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501376
Basic UDI-DI: 50560805StreptexU9
Reference: R30950501
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX POSITIVE CONTROL

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501291
Basic UDI-DI: 50560805PathoDXReagPCQV
Reference: R24042
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX STREP GROUPING KIT

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

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501239
Basic UDI-DI: 50560805PathoDXStrep98
Reference: R62025
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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Wellcolex Colour Shigella (50 tests)

WELLCOLEX COLOUR SHIGELLA

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

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080500492
Basic UDI-DI: 50560805WCShigellaNK
Reference: R30858401
EMDN: W0104080301
EMDN description: SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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Wellcolex Colour Salmonella (50 tests)

WELLCOLEX COLOUR SALMONELLA

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

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080500485
Basic UDI-DI: 50560805WCSalmonellaNB
Reference: R30858301
EMDN: W0104080301
EMDN description: SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC)
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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PATHODX HERPES TYPING CONTROL SLIDES

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

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: 02.07.2026 01:50

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PATHODX DISPOSABLE SLIDES

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501536
Basic UDI-DI: 50560805PathoDXCardE6
Reference: R62070
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX STREP GROUPING UNIVERSAL KIT

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501352
Basic UDI-DI: 50560805PathDXStrepC7
Reference: R62076
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:48

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PATHODX EXTRACTION REAGENT 1

PATHODX EXTRACTION REAGENT

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501307
Basic UDI-DI: 50560805PathoDXReagGN
Reference: R62050
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX STREP A GROUPING LATEX

PATHODX STREP GROUPING LATEX

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501246
Basic UDI-DI: 50560805PathoDXLatex3G
Reference: R62030
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:48

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PATHODX HERPES TYPING KIT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080500003
Basic UDI-DI: 50560805PathoDXHerpesW5
Reference: R62250
EMDN: W0105040301
EMDN description: HSV ANTIGEN
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:48

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IMAGEN TEFLON COATED SLIDES (100/BOX)

IMAGEN TEFLON COATED SLIDES

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384519910
Basic UDI-DI: 50560805ImagenTefSlide2F
Reference: S611430-6
EMDN: W0503900201
EMDN description: MICROSCOPE SLIDES
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:44

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SENSITITRE FRCOL

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384547845
Basic UDI-DI: 5032384SensititreFRCOLKC
Reference: FRCOL
EMDN: W0104080599
EMDN description: MANUAL SUSCEPTIBILITY TESTING - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:28

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SENSITITRE SEMEDL

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384546534
Basic UDI-DI: 5032384SEMEDLQN
Reference: SEMEDL
EMDN: W0104080599
EMDN description: MANUAL SUSCEPTIBILITY TESTING - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

SENSITITRE ARIS HIQ SYSTEM

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384545872
Basic UDI-DI: 5032384SensititreARISHQ2V
Reference: V4000
EMDN: W02030199
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:28

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SENSITITRE EUGNF

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384533930
Basic UDI-DI: 5032384SensititreEUGNFKT
Reference: EUGNF
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:28

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PATHODXTRA POSITIVE CONTROL

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384519897
Basic UDI-DI: 5032384PathoDxtraPCFJ
Reference: DR0707G
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODXTRA STREP GROUP A LATEX

PATHODXTRA STREP GROUP LATEX

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384519835
Basic UDI-DI: 5032384PathoDxtraLatexTL
Reference: DR0701G
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

PROSPECT WASH BUFFER

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384519828
Basic UDI-DI: 5032384ProSpecTWashDM
Reference: R2450001
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODXTRA DISPOSABLE CARDS

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384519606
Basic UDI-DI: 5032384PathoDxtraCardG8
Reference: DR0720G
EMDN: W0105011199
EMDN description: STREPTOCOCCAL REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details