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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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670 device results listed.

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WELLCOGEN EDTA SOLUTION

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080502076
Basic UDI-DI: 50560805WellcoEDTAAY
Reference: R30164501
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
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

STREPTEX DISPOSABLE REACTION CARDS

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501550
Basic UDI-DI: 50560805StreptexCardM4
Reference: R30368601
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

Staphaurex Disposable Reaction Cards (50 cards per pack)

STAPHAUREX DISPOSABLE REACTION CARDS

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501543
Basic UDI-DI: 50560805StapharexCardsBK
Reference: R30369001
EMDN: W0104080399
EMDN description: IMMUNOLOGICAL IDENTIFICATION - 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

Staphaurex Plus Latex Agglutination Test (150 tests)

STAPHAUREX PLUS LATEX AGGLUTATION TEST

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501512
Basic UDI-DI: 50560805StapharexPlusC6
Reference: R30950102
EMDN: W0104080303
EMDN description: STAPHYLOCOCCI SLIDE TESTS
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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Staphaurex Latex Agglutination Test (120 Tests)

STAPHAUREX LATEX AGGLUTATION TEST

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501499
Basic UDI-DI: 50560805StapharexLD
Reference: R30859901
EMDN: W0104080303
EMDN description: STAPHYLOCOCCI SLIDE TESTS
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 02.07.2026 01:50

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STREPTEX ACID EXTRACTION KIT

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501482
Basic UDI-DI: 50560805StreptexAcidExtAE
Reference: R30951301
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

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STREPTEX EXTRACTION ENZYME

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501475
Basic UDI-DI: 50560805StreptexEnzymeCU
Reference: R30951001
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

STREPTEX POLYVALENT POSITIVE CONTROL

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501468
Basic UDI-DI: 50560805StreptexPC63
Reference: R30164601
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

STREPTEX LATEX A

STREPTEX LATEX

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501406
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30950601
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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STREPTEX RAPID

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

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501390
Basic UDI-DI: 50560805StreptexAcidL5
Reference: R30950555
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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details